The tariff classification of TriPore™ from the United Kingdom

N024519 March 17, 2008 CLA-2-30:OT:RR:NC:N2:238 CATEGORY: Classification TARIFF NO.: 3004.90.9190 Ms. Joan Smith OrthoEase, LLC. 215 Horton Highway Mineola, NY 11501 RE: The tariff classification of TriPore™ from the United Kingdom Dear Ms. Smith: In your letter dated March 3, 2008, you requested a tariff classification ruling. The samples which you submitted are being returned as requested. The subject product, TriPore™ is a synthetic resorbable calcium salt bone-void filler and will be imported in measured dosage form, ready for retail sale. It is intended for use in spinal fusion procedures and can also be used for maxillofacial surgery for the reconstruction of the facial skeleton by filling voids or defects in the human skeleton. This product is gradually resorbed and is replaced with bone during the healing process. In your literature submitted to this office, there are three different types of TriPore™: TriPore HA consists of synthetic porous hydroxylapatite TriPore BP90 consists of 90% hydroxylapatite with 10% tricalcium phosphate TriPore BP15 consists of 15% hydroxylapatite with 85% tricalcium phosphate The applicable subheading for the TriPore™ in measured dosage form will be 3004.90.9190, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “"Medicaments … consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses … or in forms or packings for retail sale: Other: Other: Other: Other." The rate of duty will be free. Your proposed classification under HTSUS 9021.39.00 does not apply since your import is not an artificial part of the body like the false teeth, artificial hips, etc cited in Harmonized System Explanatory Note III to 9021. It is not the replacement for a defective body part. It is a material that is “packed into bone defects” to fill voids. We note that dental fillings, bone reconstruction cements, and bone grafts are explicitly excluded from 9021 by EN III. 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 World Wide Web at http://www.usitc.gov/tata/hts/. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. 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 Harvey Kuperstein at 646-733-3033. Sincerely, Robert B. Swierupski Director, National Commodity Specialist Division