CLA-2-90:OT:RR:NC:N3 135
James Trubits
Mohawk Global
4455 Genesee St Buffalo, NY 14225
RE: The tariff classification of a dental imaging device from China
Dear Mr. Trubits:
In your letter dated July 31, 2024, you requested a tariff classification ruling on behalf of your client, CALCIVIS Ltd.
The CALCIVIS Imaging Device consists of a wireless intra-oral imaging device handset, a Dock, and associated imaging software on a USB card, which allows both video streaming of images and capturing of still images. The handset measures 30 cm x 5 cm x 4 cm (H x W x D) and contains a camera, a rechargeable battery, a keypad, and a mechanism which is used to apply a small amount of CALCIVIS photoprotein to the tooth under investigation. The keypad includes a capture button, charge/status indicators, an up button, a selection/power button, and a down button. The dock functions as a handset stand/charger. It has a photoprotein chiller unit and can display chiller temperature. Other items packaged with the imaging device include a user manual, a power supply unit, a device cover, and a USB cable. The dock will be connected to a laptop or computer by the USB cable. The imaging software on the USB card will be installed on the laptop or computer as either a standalone or integrated to an image management system. The CALCIVIS Imaging Device and CALCIVIS Imaging Kit (the imaging kit includes photoprotein and other components that are not part of this ruling request) are used together as the CALCIVIS imaging system. The system is for use by trained dental healthcare professionals. It allows them to detect and assess demineralization associated with carious lesions.
In your letter you proposed a classification in subheading 9018.19.4000, Harmonized Tariff Schedule of the United States (HTSUS), as electro-diagnostic apparatus used for functional exploratory examination. We disagree. Functional in the medical sense means that which relates to the normal physiological activity or vital functioning, of an organ, but not the structure, or anatomy, of that organ. See Dorland’s Illustrated Medical Dictionary 667 (1994). Exploratory in the medical sense means that which relates to an active examination, usually involving endoscopy or a surgical procedure, to ascertain conditions present as an aid in diagnosis. See Stedman’s Medical Dictionary 550 (1990). According to the link you provided, the CALCIVIS Imaging System dispenses the CALCIVIS photoprotein onto the patient’s tooth. The CALCIVIS photoprotein binds to free calcium minerals in the tooth that come from the mineral loss of enamel related to active caries lesions. The free calcium minerals combined with the photoprotein give off a visible light that is captured by the camera in the handset. The images of the detected light on the patient’s tooth are used by the dental health care provider to identify active caries lesions and help develop a treatment plan. In this case, the imaging device is used to dispense the photoprotein onto the patient’s tooth and obtain images of tooth decay, as an aid to the assessment, diagnosis, monitoring, and treatment planning of demineralization. It does not meet the definitions of functional and exploratory.
The applicable subheading for the CALCIVIS Imaging Device will be 9018.19.9550, 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: [o]ther apparatus. The rate of duty will be free.
Pursuant to U.S. Note 20 to Subchapter III, Chapter 99, HTSUS, products of China classified under subheading 9018.19.9550, HTSUS, unless specifically excluded, are subject to an additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.01, in addition to subheading 9018.19.9550, HTSUS, listed above.
The HTSUS is subject to periodic amendment, so you should exercise reasonable care in monitoring the status of goods covered by the Note cited above and the applicable Chapter 99 subheading. For background information regarding the trade remedy initiated pursuant to Section 301 of the Trade Act of 1974, including information on exclusions and their effective dates, you may refer to the relevant parts of the USTR and CBP websites, which are available at https://ustr.gov/issue-areas/enforcement/section-301-investigations/tariff-actions and https://www.cbp.gov/trade/remedies/301-certain-products-china respectively.
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