Orthodontic Sheets Are Plastic Materials, Not Dental Appliances: CAAR Mumbai

In re Straumann Dental India LLP (CAAR Mumbai)

Summary: The Customs Authority for Advance Rulings (CAAR), Mumbai, ruled that orthodontic thermoforming sheets marketed as Zendura A, Zendura FLX, Zendura VIVA and Zendura TRAK are not classifiable as dental appliances or fittings under tariff item 9021 29 00. On the facts and forms of import described in Straumann Dental India LLP’s application, the Authority classified the rolls under tariff item 3920 99 99 and the pre-cut round sheets under tariff item 3926 90 99 of the First Schedule to the Customs Tariff Act, 1975. The ruling turns on the condition of the goods when imported: flat thermoplastic materials require subsequent patient-specific thermoforming before an aligner, retainer or attachment template comes into existence.

Straumann, a subsidiary of the Switzerland-headquartered Straumann Group, sought an advance ruling through Form CAAR-1 dated 25 April 2026, received on 30 April 2026. Its application covered four variants supplied as rolls and circular sheets in specified sizes. The applicant described the goods as medical-grade thermoplastic polyurethane, polyester or combinations thereof, with specialised performance characteristics and a three-layer structure. It maintained that they had no general commercial or industrial use and were exclusively intended for orthodontic applications. The manufacturing process involved extrusion of thermoplastic pellets into sheets; fabrication of the finished appliances subsequently required a dental model, heating and pressure, moulding, trimming and finishing.

The applicant relied on GRI 1, Chapter 90 Notes 1(f) and 6, and the HSN Explanatory Notes covering dental appliances that correct deformities of the teeth. It also invoked GRI 2(a), arguing that the sheets were dedicated blanks for aligners, and cited AGFA Healthcare India Pvt. Ltd. v. ADG (Adjudication), concerning medical diagnostic printers. The jurisdictional Commissionerate furnished no comments despite references dated 8 May, 1 June and 3 July 2026. Neither the applicant nor the Department appeared at the personal hearings; the applicant had been offered hearings on 9 July, 28 July and 27 October 2026. The Authority decided the application on the written submissions, technical literature and Bill of Entry on record.

CAAR found that heading 9021 covers appliances capable of performing their corrective, supportive or substitutive function. The sheets lacked the patient-specific, tooth-by-tooth geometry necessary for an orthodontic appliance. They were neither unfinished appliances possessing the essential character of the finished goods nor “blanks” within GRI 2(a), because they lacked the approximate shape or outline of an aligner. They were also raw materials rather than components incorporated as parts. The Authority further observed that tariff item 9021 29 00 concerns artificial teeth and dental fittings, whereas the applicant’s description of finished corrective aligners pointed towards orthopaedic appliances under 9021 10 00. That observation did not amount to an operative classification of finished aligners.

The Authority rejected reliance on exclusive medical end use or CDSCO regulatory status as determinative of tariff classification. Chapter 90 Note 1(f), concerning articles exclusively for implants, did not apply to materials for removable oral devices. The product literature also showed distinct functions: Zendura A was retainer material intended to maintain tooth position without active force, while Zendura TRAK produced single-use attachment-placement templates. AGFA Healthcare was distinguished because it concerned complete medical imaging printers, rather than flat plastic materials awaiting fabrication.

Applying Chapter 39 Note 10, CAAR held that the non-cellular rolls, comprising thermoplastic layers without reinforcement, support or combination with non-plastic material, fell under heading 3920. Their three-layer construction excluded the plain-sheet tariff items considered in the ruling, leading to classification under 3920 99 99. Circular sheets fell outside headings 3920 and 3921 because Note 10 permits uncut sheets or sheets cut into rectangular, including square, shapes. They were classified as other articles of plastics under 3926 90 99. The ruling expressly excludes imports in other forms, including rectangular or square sheets and pre-formed articles, and does not determine the classification of finished aligners, retainers or attachment templates. Its application remains tied to the facts furnished by the applicant.

Cases Discussed

• AGFA Healthcare India Pvt. Ltd. v. Additional Director General (Adjudication) — 2026 (2) TMI 1035; Customs Appeal Nos. 50795 and 50796 of 2020, decided on 20.02.2026 (CESTAT Delhi). The applicant relied on the medical-specific design of the printers. CAAR distinguished the decision because it concerned finished apparatus, whereas the imported sheets were raw materials.
• Collector of Customs, Bombay v. Business Forms Ltd. — 2002 (142) E.L.T. 18 (Supreme Court). Cited by the applicant for the use of HSN Explanatory Notes as a guide to tariff interpretation.

FULL TEXT OF THE ORDER OF CUSTOMS AUTHORITY OF ADVANCE RULING, MUMBAIध्यान दीजिए/ N.B.:

1. M/s. Straumann Dental India LLP (IEC No.: 0516508563) (“the Applicant”) filed an application in Form CAAR-1 dated 25.04.2026 for advance ruling in the Office of the Secretary, Customs Authority for Advance Rulings (CAAR), Mumbai. The said application was received in the secretariat of the CAAR, Mumbai on 30.04.2026 along with its enclosures in terms of Section 28H(1) of the Customs Act, 1962 (hereinafter referred to as “the Act’), seeking advance ruling on the classification of orthodontic thermoforming sheets marketed as Zendura A, Zendura FLX, Zendura VIVA and Zendura TRAK, which the applicant proposes to import.

2. Question(s) on which Advance Ruling is required:

Question 1: Whether the orthodontic thermoforming sheets in question, i.e., Zendura A, Zendura FLX, Zendura VIVA and Zendura TRAK, are classifiable under Tariff Item 9021 29 00 of the First Schedule to the Customs Tariff Act, 1975?

Question 2: If the products mentioned above are not classifiable under the Tariff Item as mentioned above, then what would be the correct classification of the above products under the Tariff?

3. Applicant’s eligibility for Advance Ruling: The applicant holds a valid IEC No. 0516508563 and therefore qualifies as an “applicant” under Section 28E(c) of the Customs Act’ 1962. The questions on which the advance ruling is sought relate to the classification of goods, and therefore fall under clasue (a) of Section 28H(2). The relevant Section of the Customs Act 1962 has been reproduced below:

Section 28E. Definitions. —

(c) “applicant” means any person, –

(i) holding a valid Importer-exporter Code Number granted under section 7 of the Foreign Trade (Development and Regulation) Act, 1992; or Section 28H. Application for advance ruling. –

(1) An applicant desirous of obtaining an advance ruling under this Chapter may make an application in such form and in such manner and accompanied by such fee as may be prescribed, stating the question on which the advance ruling is sought.

(2) The question on which the advance ruling is sought shall be in respect of, –

(d) applicability of notifications issued in respect of tax or duties under this Act or the Customs Tariff Act, 1975 (51 of 1975) or any tax or duty chargeable under any other law for the time being in force in the same manner as duty of customs leviable under this Act or the Customs Tariff Act

The applicant has declared that no proceedings involving the same issue are pending before any Customs authority, Appellate Tribunal or any Court of Law. Accordingly, the application appears admissible under Section 28-I (2) of the Customs Act, 1962.

4. Applicant’s Submissions

4.1 The Applicant is a limited liability partnership incorporated in the year 2016 under the Limited Liability Partnership Act, 2008 (LLPIN: AAH-7013), having its registered office at 501, 5th Floor, Alpha Building, Hiranandani Business Park, Powai, Mumbai — 400 076. The Applicant is a subsidiary of the Straumann Group, a multinational corporation headquartered in Basel, Switzerland, and is engaged in the business of importing, trading and distributing dental implants, instruments, prosthetics and biomaterials to the healthcare and medical equipment sector in India.

4.2. The application has been filed in respect of four variants of “Zendura” orthodontic thermoforming sheets. Each variant is available in rolls and in pre-cut round sheets of various thicknesses and diameters. The SKUs covered by the application, as listed in Exhibit-5 to the application, are summarised below:

About Orthodontic Thermoforming Sheets

4.3 Orthodontic thermoforming sheets are specialised medical-grade polymers engineered to be thermoformed over a patient-specific dental model to produce clear aligners, specifically designed for intra-oral use and for delivering controlled orthodontic forces to correct malocclusions. They are made from thermoplastic polyurethane / polyester or combinations thereof (herein refer to as “thermoplastic”), and are ultra-clear, highly stain-resistant and free from BPA, phthalates and gluten.

4.4 As per the applicant, the sheets have a three-layer structure which is as follows:

1) Two outer layers: These layers provide structural integrity and crack resistance and adapt to tooth movement. They ensure long-lasting wear, protect against breakage and maintain clarity.

2) Inner layer: This layer offers dynamic force retention and is engineered to maintain consistent pressure over time, delivering sustained orthodontic force.

The sheets are available in different forms, grades, compositions and performance layers depending upon the clinical requirements of aligner therapy.

4.5 The sheets exhibit functional features such as biocompatibility, chemical resistance, stain resistance, low water absorption, optical clarity and thermoforming stability, which are essential for sustained intra-oral wear over multiple days/ weeks. The applicant submits that the actual use of these orthodontic thermoforming sheets is exclusively in orthodontic operations. They are classified as Class A medical- grade materials and are manufactured under a medical device licence.

4.6 The sheets are thermoformed, trimmed. polished and converted into custom aligners for patients. Their specifications and composition are approved only for dental and orthodontic use. ensuring compliance with the relevant quality and safety standards. They are not marketable as generic materials and have no commercial or industrial use outside orthodontic aligner fabrication.

4.7 The sheets are supplied in standard circular blanks or rolls of defined thickness, diameter and multilayer composition optimised for aligner fabrication. According to the applicant, the variants differ only in technical performance characteristics and not in end use, which remains exclusively the manufacture of orthodontic clear aligners.

Process of manufacture of Orthodontic Thermoforming sheets

4.8 Orthodontic thermoforming sheets are manufactured through an extrusion process. The detailed steps involved in the manufacturing are as follows:

• Material Preparation: Thermoplastic pellets are dried to prevent defects such as bubbles or silver streaks, as the material is highly moisture-sensitive. Typical drying conditions range from 1 to 3 hours at 80 – 110°C.
• Melting and Plasticizing: The dried pellets are fed into a sheet extrusion line (generally using a single-screw extruder) where they melt and plasticize due to applied heat and shear.
• Extrusion: The molten thermoplastic is forced through a flat, slot-shaped die, forming a continuous sheet.
• Cooling: The sheet passes through chill rolls to cool and solidify to the required thickness and finish.
• Winding: The finished sheet is cut into individual blanks for use as orthodontic thermoforming sheets.

Process of manufacture of the sheets and of aligners from the sheets

4.9 Aligners are made from the sheets by the following process: (i) a dental model is prepared and cured; (ii) the thermoformer is heated and the dental model is placed on its platform; (iii) the orthodontic thermoforming sheet is placed in the thermoforming frame, where heat and pressure mould it to the shape of the dental model; (iv) after forming, the moulded sheet is removed; and (v) the formed aligner is separated from the model and excess edges are trimmed and finished.

4.10 The product is imported solely in the form of circular discs or rolls for ease of transportation, handling and storage. Owing to its unique multilayer structure. medical-grade formulation and engineering specific to orthodontic force delivery, the product has no other commercial, industrial or general-purpose use apart from orthodontic applications. These sheets can only be used to manufacture clear aligners, as they are not marketable as generic plastic sheets and derive their utility exclusively from thermoforming into patient-specific aligners. The imported goods are therefore supplied in this sheet structure purely for logistical efficiency. while their functional use remains restricted entirely to orthodontic aligner fabrication.

4.11 Applicant’s Interpretation of the Questions Raised

Applicant’s Interpretation on Question 1

4.11.1 The applicant submits that under Rule 1 of the General Rules for the Interpretation of the First Schedule (“GRI”), classification is determined according to the terms of the headings and any relative Section or Chapter Notes. The Tariff is aligned with the Harmonized System up to the six-digit level and the HSN Explanatory Notes are a safe guide for interpretation, as held by the Hon’ble Supreme Court in the case of Collector of Customs, Bombay vs. Business Forms — 2002 (142) ELT 18.

4.11.2 Note 1(f) to Chapter 90 provides that, although parts of general use of base metal or similar goods of plastics are excluded from Chapter 90, “articles specially designed for use exclusively in implants in medical, surgical, dental or veterinary sciences are to be classified in heading 9021”. Note 6 to Chapter 90 defines “orthopaedic appliances” to include appliances for preventing or correcting bodily deformities. Hence, articles specially designed for exclusive dental or orthodontic corrective use must be classified under heading 9021 irrespective of their material composition, even when made of plastics.

4.11.3 The HSN Explanatory Notes to heading 9021 expressly include “dental appliances for correcting deformities of the teeth (braces, rings, etc.)”.

4.11.4 The applicant relies on AGFA Healthcare India Pvt. Ltd. v. ADG (Adjudication), 2026 (2) TMI 1035 (CESTAT, New Delhi), wherein medical printers sharing technological characteristics with general printers of Chapter 84 were held classifiable in Chapter 90 on account of their specific design for medical diagnostic use. The tribunal emphasized that specialised adaptation for medical purposes prevails over the general nature of the underlying technology or material.

4.11.5 The orthodontic thermoforming sheets being exclusively designed for orthodontic corrective treatment, possessing no commercial or general-purpose plastic application and only used in manufacture of dental appliances for correcting deformities of the teeth and hence, classifiable under Heading 9021, more specifically Tariff Item 9021 2900 (“Other”).

4.11.6 The applicant further relies on GRI 2(a) and the HSN Explanatory Note thereto relating to “blanks”, contending that the sheets qualify as blanks for forming aligners since they are manufactured in orthodontic-specific thicknesses, presented in aligner-grade diameters and possess a force-retentive multilayer structure usable only for clear aligner fabrication. Although the sheets do not have the shape of the finished aligner at the time of import, their single-use, dedicated and exclusive orthodontic application is stated to align with the HSN description of blanks i.e., articles not ready for direct use, which can only be completed into one specific finished article. The applicant also points out that the Explanatory Notes to heading 9021 list items such as prefabricated crowns, cast tin bars and other identifiable accessories for making crowns or dentures such as sockets, rings, pivots, hooks, eyelets, etc., to contend that heading 9021 extends to specialised inputs used exclusively in the manufacture of dental corrective devices.

4.11.7 The sheets are imported in the form of circular discs or rolls solely for logistical convenience and ease of transportation, and not because they are intended to serve as plastic sheets for any general-purpose use. Their exclusive functional purpose remains the manufacture of orthodontic clear aligners, i.e., dental appliances for correcting deformities of the teeth. Accordingly, as per the applicant the imported orthodontic thermoforming sheets are classifiable under Tariff Item 9021 2900.

4.11.8 By application of Note 1(f) to Chapter 90, the sheets are, according to the applicant, not classifiable under Chapter 39 and are rightly classifiable under heading 9021 as dental appliances.

4.11.9 Accordingly, the applicant’s understanding is: Question 1 — Yes, the goods are classifiable under Tariff Item 9021 29 00; Question 2 — Not applicable.

5. Port of Import and reply from jurisdictional Commissionerate:

The applicant in their CAAR-1 indicated that they intend to import the subject goods at the jurisdiction of The Commissioner of Customs, NS-V, JNCH, Nhava Sheva, Raigad — 400 707. Accordingly, the application was forwarded to the concerned Commissionerate for their comments on 08.05.2026, 01.06.2026 and 03.07.2026.

No comments have been received from the jurisdictional Commissionerate till date.

6. Details of Personal Hearing:

The applicant, vide emails dated 03.07.2026, 21.07.2026 and 16.10.2026 was requested for Personal Hearing on 09.07.2026, 28.07.2026 and 27.10.2026 respectively. However, no representative appeared on behalf of the applicant at the time of the personal hearing on either of the said dates.

6.1 No representative appeared on behalf of the Department at the time of the personal hearing.

7. Discussion and Findings

7.1. I have carefully considered the application, the written submissions of the applicant, the technical literature and the Bill of Entry placed on record.

7.2. The issues raised in Question 1 and 2 in the Form CAAR-1 are covered under Section 28H (2) of the Customs Act, 1962, being matter of classification and of applicability of import duty benefit notification. The questions posed for advance ruling are:

Question 1: Whether the orthodontic thermoforming sheets in question, i.e., Zendura A, Zendura FLX, Zendura VIVA and Zendura TRAK, are classifiable under Tariff Item 9021 29 00 of the First Schedule to the Customs Tariff Act, 1975?

Question 2: If the products mentioned above are not classifiable under the Tariff Item as mentioned above, then what would be the correct classification of the above products under the Tariff?

7.3. The goods as presented for import

7.3.1. As per the applicant, the goods are flat, transparent, thermoforming sheets made from thermoplastic polyurethane / polyester or combinations thereof (hereinafter referred to as “thermoplastic”). The goods are imported in sheet form of standard circular blanks or rolls of defined thickness, presented either (a) as continuous rolls or (b) as circular sheets.

7.3.2. As per applicant’s submission and the Bill of Entry placed on record describe the goods as “raw material for manufacture of plastic dental aligner”. The goods are referred to as “Orthodontic Thermoforming Sheet”.

7.4. Whether the goods are classifiable under Tariff Item 9021 29 00 (Question 1)

7.4.1. Under Rule 1 of the GRI, classification is determined according to the terms of the headings and any relative Section or Chapter Notes and, provided such headings or Notes do not otherwise require, according to the remaining Rules. Under Rule 6, classification in the subheadings of a heading is determined according to the terms of those subheadings and any related Subheading Notes. The relevant entries of heading 9021 are extracted below:

7.4.2. The relevant Notes to Chapter 90 read as under:

Note 1. This Chapter does not cover: … (f) parts of general use, as defined in Note 2 to Section XV, of base metal (Section XV) or similar goods of plastics (Chapter 39); however, articles specially designed for use exclusively in implants in medical, surgical, dental or veterinary sciences are to be classified in heading 9021, …

Note 6. For the purposes of heading 9021, the expression “orthopaedic appliances” means appliances for: — preventing or correcting bodily deformities; or — supporting or holding parts of the body following an illness, operation or injury. Orthopaedic appliances include footwear and special insoles designed to correct orthopaedic conditions, provided that they are either (1) made to measure or (2) mass-produced, presented singly and not in pairs and designed to fit either foot equally.

7.4.3. Heading 9021 is a heading for appliances namely orthopaedic appliances, splints and other fracture appliances, artificial parts of the body, hearing aids and other appliances which are worn or carried, or implanted in the body. Note 6 defines orthopaedic appliances as appliances for preventing or correcting bodily deformities or supporting or holding parts of the body, and the HSN Explanatory Notes to heading 9021 (Part I, item 7) refer to “dental appliances for correcting deformities of the teeth (braces, rings, etc.)”. Every good is itself the appliance and is capable of performing its corrective, supportive or substitutive function on the body. A flat roll or round sheet of thermoplastic is not capable, in that condition, of being worn, and cannot prevent or correct any deformity of the teeth. It is the patient-specific geometry imparted by thermoforming — engineered for a particular tooth movement at a particular stage of treatment — that makes an aligner an orthodontic appliance; that geometry is wholly absent from the imported goods. The sheets are raw material for making orthodontic appliance and not an orthodontic appliance, therefore the sheets are not “appliances” of heading 9021.

7.4.4. Under Rule 2(a) of the General Rules for Interpretation, a reference to an article includes that article incomplete or unfinished, provided that, as presented, it has the essential character of the complete article. The HSN Explanatory Note (II) to Rule 2(a) describes a “blank” as an article, not ready for direct use, “having the approximate shape or outline of the finished article or part”, and expressly states that “semi-manufactures not yet having the essential shape of the finished articles (such as is generally the case with bars, discs, tubes, etc.) are not regarded as “blanks”. The applicant itself submits that the sheets do not have the shape of the finished aligner and are raw materials for making aligners. The round sheets are discs and the rolls which are precisely excludes from the concept of a blank by the Explanatory Notes. The essential character of an aligner lies in its patient-specific, tooth-by-tooth geometry, which the sheets do not possess. Nor the sheets are “parts” as a part is a component that is incorporated into a finished article whereas the sheet is the raw material out of which the whole aligner is formed, and it loses its identity as a sheet in that process. The sheets are also not the “parts” of an appliance. Further, the Rules are to be applied sequentially, and the said is applicable only where the terms of the headings and Notes do not otherwise determine classification; as discussed below, the headings and Notes of Chapter 39 specifically describe the goods. Rule 2(a) is, therefore, not applicable here.

7.4.5. The tariff item proposed by the applicant, 9021 29 00, falls under the group “Artificial teeth and dental fittings”. The HSN Explanatory Notes to heading 9021 Part III, describe artificial parts of the body as articles which “wholly or partially replace defective parts of the body”, and “artificial teeth and dental fittings such as solid/ hollow artificial teeth, dentures, crowns and various other articles such as metal crowns for protection of teeth, cast tin bars for weighting and increasing the stability of dentures, stainless steel bar for reinforcing vulcanised rubber dental plates and other dental accessories clearly identifiable as such for making metal crowns or dentures (sockets, rings, pivots, hooks, eyelets, etc.)”. An aligner, retainer or attachment template does not replace any part of the body and is not a dental fitting. In fact, applicant has stated that the finished aligners are “dental appliances for correcting deformities of the teeth” and the appropriate subheading for such finished appliances would be 9021 10 00 (orthopaedic appliances), and not 9021 29 00. The claim to Tariff Item 9021 29 00 is thus misconceived even on the applicant’s own reasoning.

7.4.6. Note 1(f) to Chapter 90: Note 1(f) to Chapter 90 excludes parts of general use (as defined in Note 2 to Section XV, i.e. screws, bolts, nuts, springs and the like) of base metal and similar goods of plastics, but also says that “articles specially designed for use exclusively in implants in medical, surgical, dental or veterinary sciences are to be classified in heading 9021”. The sheets are neither parts of general use nor articles for use in implants; aligners, retainers and attachment templates are removable oral devices and not implants. Note 1(f) is therefore has not applicable to the subject goods.

7.4.7. Exclusive end use. That the sheets are made of medical-grade materials and are put only to orthodontic use does not convert a material into an appliance. Heading 9021 does not say anything related to the end use of materials. Even other materials meant exclusively for dentistry are classified as materials in their own headings such as dental cements, dental wax etc., and not as dental appliances or fittings. Likewise, the listing of the goods on the CDSCO portal as a Class A device under the Medical Devices Rules is a matter of regulatory control under a different statute and cannot govern classification under the Tariff.

7.4.8. The product literature placed on record further undermines the premise that all four variants are materials “engineered for delivering corrective orthodontic force”. Zendura A is described as retainer material, the primary job of a retainer being stated to be “to maintain tooth position without active force application”; and Zendura TRAK is used to make attachment templates, which are single-use guides used by the clinician to position composite attachments on the teeth and are not appliances worn to prevent or correct a deformity. Thus, it can be seen that sheets of the same physical form are converted, after import, into different articles (aligners, retainers or attachment templates) which confirms that it is the post-import forming operation, and not the sheet, that determines the article.

7.4.9. The decision in AGFA Healthcare India Pvt. Ltd. (supra) concerned complete printers specially designed for medical diagnostic imaging, where the contest was between two headings each covering finished machines or apparatus (8443 and 9018). In the present case the goods are not finished apparatus or appliances, but flat plastic films.

7.4.10. In view of the above, I find that the orthodontic thermoforming sheets are not classifiable under Tariff Item 9021 29 00, or under any other tariff item of heading 9021.

7.5. Correct classification of the goods (Question 2)

7.5.1. Note 1 to Chapter 39 defines “plastics” as “those materials of headings 3901 to 3914 which are or have been capable, either at the moment of polymerisation or at some subsequent stage, of being formed under external influence (usually heat and pressure, if necessary, with a solvent or plasticiser) by moulding, casting, extruding, rolling or other process into shapes which are retained on the removal of the external influence”. Also, the HSN Explanatory notes to Chapter 39 define “thermoplastic” as “material of this Chapter which can be softened repeatedly by heat treatment and shaped into articles, e.g., by moulding, and then hardened by cooling, it is termed “thermoplastic”. The subject goods referred here are thermoplastic polyurethane and polyester sheets are apt for this description as their very utility is of being re-formed under heat and pressure. Note 2 to Chapter 39 excludes articles of Chapter 90; since the goods have been found above not to be articles of Chapter 90, that exclusion does not apply here. The goods are, therefore, classifiable in Chapter 39.

7.5.2. The relevant entries of Chapter 39 are as follows:

7.5.3. Note 10 to Chapter 39 provides: “In headings 3920 and 3921, the expression ‘plates, sheets, film, foil and strip’ applies only to plates, sheets, film, foil and strip (other than those of Chapter 54) and to blocks of regular geometric shape, whether or not printed or otherwise surface-worked, uncut or cut into rectangular (including square) shapes but not further worked (even if when so cut they become articles ready for use).”

7.5.4. Rolls: The rolls are continuous strip of plastics of uniform width, neither cut to shape nor otherwise further worked, and are squarely covered by the expression “plates, sheets, film, foil and strip” in Note 10. The heading 3921 covers such products which are cellular, or which are reinforced, laminated, supported or similarly combined with other materials. However, the goods on record are not cellular and their multilayer structure consists solely of layers of thermoplastic with no reinforcement, support or combination with other non-plastic material such as textile, paper or metal. The rolls are therefore classified in heading 3920. Further, the sheets, as submitted by the applicant, are of a three-layer construction (dual outer shells with an elastomeric middle layer) and are therefore not plain sheets of Tariff Items 3920 99 91 or 3920 99 92. The goods are of “thermoplastic polyurethane / polyester or combinations thereof” and therefore classify under tariff item 3920 99 99.

7.5.5. Round sheets: The round sheets are sheets are cut to a circular shape and therefore outside the expression “plates, sheets, film, foil and strip” as defined in Note 10 and cannot be classified in heading 3920 or 3921. The round sheets fall in heading 3926 as other articles of plastics, under subheading 3926 90 (Other). Not being of polyurethane foam, they are appropriately classifiable under Tariff Item 3926 90 99.

7.5.6 Goods are classified in the form and condition in which they are presented for import, and not in the form of the article that may later be made out of them. At the time of import, the sheets bear no relationship to the dentition of any patient. The aligner, retainer or attachment template comes into existence only after import.

8. Ruling

8.1. In view of the foregoing discussion and findings, I rule that the orthodontic thermoforming sheets, namely Zendura A, Zendura FLX, Zendura VIVA and Zendura TRAK, in the form of rolls and round sheets as described in the application, are not classifiable under Tariff Item 9021 29 00 of the First Schedule to the Customs Tariff Act, 1975.

8.2. I further rule that the said goods are classifiable in Chapter 39 of the First Schedule to the Customs Tariff Act, 1975, as under:

8.3. The ruling is pronounced on the facts furnished by the applicant, and under Section 28J(3) of the Act a ruling ceases to apply where those facts change. It does not apply to the said goods if imported in any other form (for example, rectangular or square sheets, or pre-formed articles), nor does it determine the classification of the aligners, retainers or attachment templates fabricated from the sheets.

8.4. I rule accordingly.