CLA-2-90:OT:RR:NC:N3 135
Tawni Myers
Align Technology, Inc.
410 N Scottsdale Road, Suite 1300 Tempe, AZ 85288-7094
RE: The tariff classification of an iTero Lumina disposable sleeve from Mexico
Dear Ms. Myers:
In your letter dated November 22, 2024, you requested a tariff classification ruling. Additional information was provided via email, dated November 27, and November 29, 2024.
The product under consideration is an iTero Lumina Disposable Sleeve (SKU# 215470) made of plastic with a small glass window on top. The product is described as a single-use disposable “spectacle frame” designed for and used exclusively with an iTero Lumina intraoral scanner. The intraoral scanner consists primarily of a full HD touch-screen computing unit and a wand (scanning unit) and uses optical scanning technology to capture high-resolution 3D images of a patient's teeth, oral tissues, and bite relationships. Data generated from iTero Lumina may be used in conjunction with the production of dental restorations, orthodontic appliances, etc. The iTero Lumina intraoral scanner is indicated for oral health assessment and dental treatment planning and follow-up. The disposable sleeve will be clicked in or clicked out of the tip of the wand.
You state that the disposable sleeve serves three primary functions during the scanning operations: (1) bacterial and viral cross-contamination prevention; (2) as a protective barrier of the optical window on the scanner wand, safeguarding it from physical damage such as scratches and breakage; (3) as a thermal barrier, preventing discomfort caused by heat generated at the wand tip. Without the sleeve, the wand tip can reach temperatures up to 51ºC during scanning, which may cause patient discomfort. You claim that the iTero Lumina Disposable Sleeve goes well beyond providing a simple protective barrier and contributes directly to the core operational functionality of the scanning device (i.e. ensuring the ability of the scanner to render accurate images). You explain that the sleeve is necessary to ensure the scanner obtains an accurate rendering by protecting the optical scanner from accidental reflections from contact, physical damage from scratches, leaks, and inconsistent light refraction that affect the rendition’s precision. Therefore, you claim it is necessary and critical allowing the scanner to maintain a consistent high-quality performance during the scanning procedures and prevents possible discomfort, injury, or cross-contamination during the use of the scanner. The scanner is not designed or intended to be used without the sleeve and cannot function fully as designed without the sleeve.
In your letter, you suggest that the iTero Lumina Disposable Sleeve is an accessory of the iTero Lumina intraoral scanner and classified in subheading 9018.49.8080, Harmonized Tariff Schedule of the United States (HTSUS), which provides, in relevant part, for accessories of other instruments and appliances used in dental sciences. We concur that the iTero Lumina Disposable Sleeve is an accessory of the iTero Lumina intraoral scanner but disagree with the classification. HQ ruling H011145, dated August 16, 2007, explains that “diagnostic” entails the making of or aiding in a diagnosis. In the ruling, the four computed radiography systems do not actually make a diagnosis; however, they do aid in diagnosis by producing a digital image of an x-ray thereby allowing an evaluation of the images by which a diagnosis can be made. Customs and Border Protection determined that they fell within the ambit of electo-diagnostic apparatus and were classified in subheading 9018.19.95, HTSUS. While the iTero Lumina intraoral scanner does not diagnose an illness per se, it assists in identifying structural issues (such as bite misalignments), gum health, or other potential concerns. In our opinion, it is an electo-diagnostic apparatus. As such, the sleeve will be classified as an accessory of an electo-diagnostic apparatus.
The applicable subheading for the iTero Lumina Disposable Sleeve will be 9018.19.9560, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “[i]nstruments and appliances used in medical, surgical, dental or veterinary sciences …: [e]lectro-diagnostic apparatus …: [o]ther: [o]ther: [o]ther: [p]arts and accessories.” The rate of duty will be free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/.
The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Fei Chen at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division