N324895

N324895 March 29, 2022 CLA-2-84:OT:RR:NC:N1:104 CATEGORY: Classification TARIFF NO.: 8479.89.9585; 9903.88.03 Rick Van Arnam, Esq. Barnes, Richardson & Colburn, LLP 100 William Street New York, NY 10038 RE: The tariff classification of ultrasonic cleaning appliances from China. Dear Mr. Van Arnam: In your letter dated March 18, 2022, you requested a tariff classification ruling on behalf of your client, BrandMAX, Inc. for TriClean ultrasonic cleaning appliances. The following models are included in the ruling request: U-10LHREC, U-13LH, U-13LHREC, U-19LHREC and U-20LHREC. Model U-10LHREC is a recessed unit with a 10-liter tank capacity and has overall dimensions of 18.6 x 16.2 x 11.5 (inches). Model U-13LH is a countertop unit with a 13-liter tank capacity and overall dimensions of 14.75 x 13.75 x 12 (inches). Model U-13LHREC is a recessed unit with a 13-liter tank capacity and has overall dimensions of 13 x 11.8 x 6. Model U-19LHREC is a recessed unit with a 19-liter tank capacity and has overall dimensions of 19.25 x 18.10 x 15 (inches). Model U-20LHREC is a recessed unit with a 20-liter tank capacity and has overall dimensions of 26.75 x 18.6 x 12 (inches). Each of the ultrasonic cleaning appliances in the ruling request operate in the same way. Specifically, the load cleaning tank is filled with water, dental tools and instruments are placed in instrument cassettes and baskets, the appliance is then switched on and the resistor in the heating element converts the electric energy flowing from the office outlet into thermal energy, which increases the temperature of the cleaning solution in the tank. Each tank is equipped with a sensor to detect when the temperature is reached, and to switch off the heating element once the desired temperature is reached. This temperature is maintained by sensors in the tank which will switch the heater back on. The units have a built-in power generator that converts the available AC found in a power outlet (110V/60Hz ) into a significantly higher voltage and faster cycle to create an ultrasonic frequency via the unit’s transducers. A mechanical force of 40,000 vibrations per second is created. This will radiate though the solution in the tank. Alternating high- and low-pressure waves in the solution are caused which creates the formation and subsequent implosion of millions of microscopic bubbles. The release of energy in this process provides the level of cleaning needed to remove infectious bioburden from the media within the unit’s cassettes/baskets placed into the tank. Once the cleaning cycle is completed, the tank is drained via a drain valve. Sterilization is not performed in the unit. In your letter you believe that the ultrasonic cleaning appliances should be classified in subheading 9018.49.8080, Harmonized Tariff Schedule of the United States (HTSUS), as "other" instruments and apparatus used in dental sciences. We disagree. The appliances are used to clean dental tools and instruments prior to the sterilization process at a dental office or laboratory. They are not instruments or appliances used by dentists to “make a diagnosis, to prevent or treat an illness, or to operate.” Accordingly, heading 9018, HTSUS, does not apply to these items. You mentioned that the products are designated as medical devices by the FDA, however we note that “articles are classified by the FDA to protect public safety, not as guidance for classification of imported merchandise … Recognition by the FDA … does not constitute a determination of its tariff classification.” See Headquarters Ruling Letter H265244 (June 1, 2015). Therefore, FDA designation as a medical device does not dictate classification in heading 9018. The applicable subheading for the BrandMax TriClean ultrasonic cleaning appliances, Models U-10LHREC, U-13LH, U-13LHREC, U-19LHREC and U-20LHREC will be 8479.89.9585, HTSUS, which provides for Machines and mechanical appliances having individual functions, not specified or included elsewhere in this chapter; parts thereof: Other machines and mechanical appliances: Other: Other: Ultrasonic cleaning devices. The rate of duty will be 2.5 percent ad valorem. Products of China classified under subheading 8479.89.9585, HTSUS, unless specifically excluded, are subject to the additional 25 percent ad valorem rate of duty. At the time of importation, you must report the Chapter 99 subheading, i.e., 9903.88.03, in addition to subheading 8479.89.9585, HTSUS, listed above. See U.S. Note 20 to Subchapter III, Chapter 99, HTSUS. 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 Section 301 trade remedy, 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 on the World Wide Web at https://hts.usitc.gov/current. This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist Denise Hopkins at denise.hopkins@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division