The country of origin of dental needle tips

N343771 November 26, 2024 OT:RR:NC:N3:135 CATEGORY: Origin Will Planert Morris, Manning & Martin, LLP 1333 New Hampshire Avenue, NW ,Suite 800Washington, DC 20036 RE:  The country of origin of dental needle tips Dear Mr.. Planert: In your letter dated November 5, 2024, on behalf of Inter-Med, Inc. (d/b/a “Vista Apex”), you requested a country of origin ruling on dental syringe tips.  Additional information was provided by email, dated November 11, 2024. The products under consideration are Pre-bent Tips, MST Universal Pre-bent Tips, Appli-Vac Bendable Tips, Appli-Vac Irrigation Tips, and Vista Probe Irrigation Tips.  When attached to a syringe, these tips serve as delivery tips to deliver dental solutions and materials in the oral cavity.  Each dental syringe tip will consist of two to three parts: all consist of (1) a thin hollow tube (also referred to as "cannula” or “needle” in your letter), (2) a plastic hub adapter (“hub”), and (3) optionally – a plastic sheath (cap).  Only the tubes of Pre-bent Tips and MST Universal Pre-bent Tips are bent to fixed angles with a blunt end.  Appli-Vac Bendable Tips have blunt end straight tubes.  The tubes of Appli-Vac Irrigation Tips are slotted and side-vented.  Vista Probe Irrigation Tips have closed end tubes with a side port.   The pre-cut tubes will be manufactured in Japan, South Korea, or India.  The plastic hubs, and sheaths if present, will be sourced in China.  Assembly of the finished dental syringe tips will be performed in China.  The processing to produce the complete dental syringe tips is described in your letter as follows:  Manufacture of Cannula in Japan, South Korea, or India:  A flat strip of stainless steel will be rolled and laser-welded into a tube shape.  The tube will be cold-worked through a die several times to toughen it and reduce the size down to the specified gauge dimensions, ranging from 16ga to 31ga.  An electric blade will cut the tubing to individual cannulas at specified lengths.  A grinding machine will then create any specified features on the cannula end, including slotted/skive cuts or side ports.  Some cannulas, as in the case with side port tips, will undergo another step to close the end off through crimping or laser-welding.  Next the cannula will undergo heat treatment, either tempering or annealing to give the cannula its desired ductility, electropolishing to remove any burrs and give it luster, and citric acid passivation for rust prevention.  All of the manufacturing processes require highly specialized machinery and skilled labor, and inspections are performed at each step.  Assembly and Packing in China:  To complete the assembly of a syringe tip using the cannula and hub, an automated assembly machine will be utilized.  The machine will be loaded with components, and automatically take the plastic hub, insert a cannula, apply an epoxy, cure the epoxy with flashes of ultraviolet radiation, and may optionally bend the cannula.  No processing will be performed to the cannulas or hubs at the facility other than this assembly.  After assembly, the tips will be packaged in multiple configurations to match SKUs specified by Vista Apex.  A sheath may be placed on individual tips, and tips will be packaged in cups, bags, or blister packs at various quantities.  These cups, bags, or packs will be placed in corrugate boxes for shipping.  The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. The "country of origin" is defined in 19 CFR 134.1(b) as "the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the 'country of origin' within the meaning of this part." The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character or use, different from that possessed by the article prior to processing.  See Texas Instruments Inc. v. United States, 69 C.C.P.A. 151 (1982).  However, if the manufacturing or combining process is merely a minor one that leaves the identity of the article intact, a substantial transformation has not occurred.  Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff’d, 702 F.2d 1022 (Fed. Cir. 1983).  A substantial transformation determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff'd, 989 F.2d 1201 (Fed. Cir. 1993).  The issue of whether a substantial transformation occurs is determined on a case-by-case basis.  See HQ 561353, dated September 19, 2002.  In this case, the assembly and packaging performed in China are simple and minor processes.  Specifically, the assembly of the dental syringe tips will be performed via a mechanically automated process that solely consists of adhering the components together with an epoxy solution and flashes of ultraviolet radiation.  Depending on the product, the tube may be bent to a fixed angle.  The mechanized assembly of the components will be a highly repetitive, low-skill function that merely requires the assembly line be switched on and that adhesive epoxy be utilized.  The additional processing of the dental syringe tips will merely consist of placing the sheaths on the tips, if present, and packaging.  These processes do not change the name, character, and use of the pre-cut, pre-processed stainless-steel tubes.  You explain that the bending is purely optional and for user preference and convenience where the doctor prefers a pre-bent tip instead of bending the tips themselves prior to or during use.  You state that the bending does not significantly impact the use of the tip.  As such, we find that no substantial transformation occurs in China and the tubes are the essence of the dental syringe tips and determine the origin of the products.  Accordingly, the country of origin of the dental syringe tips will be Japan, South Korea, or India depending on the country of origin of the pre-cut, pre-processed stainless steel tubes.  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 fei.chen@cbp.dhs.gov.   Sincerely, Steven A. Mack Director National Commodity Specialist Division