CLA-2-90:RR:NC:N1:105 R00766
Mr. Carl Paul Van Lierde
Materialise NV
Technologielaan 15
Leuven 3000 Belgium
RE: The tariff classification of Dental Related Items from Belgium
Dear Mr. Van Lierde:
In your letter dated August 30, 2004, you requested a tariff classification ruling. No samples were submitted.
You describe your imports as follows:
“2. Intended use
The drills are intended to be used to drill the cavities in the jaw of the patient where afterwards dental implants will be placed into. The implant holders, screw driver, flat key and handpiece connector are tools used during placement of dental implants.
3. Product description
3.1. Drills
There are two different drill designs: a two-staged pilot drill and a singled-staged final drill. Specific features of the SAFE drills include a flange acting as a physical stoop during drilling and wider-than-standard windings to more effectively remove bone. Several drill lengths are available for different implant lengths.
The pilot drill in the SAFE-system is helicoidal. The cutting surface of the drill has two stages with different diameters. The top part of the drill, having the smallest diameter, creates a primary cavity that is enlarged immediately by the second part of the cutting surface, which has a larger diameter. This diameter is the same as that of the final drill, which is used to create a uniform width over the entire length of the implant cavity.
The connection pieces of both drills and trephine are in accordance to the ISO standard 1797-1 (Dental rotary instruments: Shanks. Part 1: Shanks made of metals).
All drills have a laser mark (e.g. a numeral) that corresponds to the respective lengths of the cutting surfaces. Available drill lengths are: 10, 13, 15, 18, 20, 23, and 25 mm
All drills are intended for single use
3.2. Implant holder and handpiece connector
The implant holder serves as an intermediate tool for transmitting to the implant the torque applied by the driving tool (i.e. dental motor) when inserting the implant into the bone. It is used for delivery of the implant to the surgical site and driving it into the osteotomy (e.g. the cavities in the jaw prepared by drilling). The implant holder is attached to the implant by means of a screw and/or a ‘tongue & groove’ fitting. By means of the handpiece connector, the component can be used in
Combination with either a uni-grip screwdriver or a motor.
Once the implants have been placed in the jaw of the patient, the implant holders are removed.
Implant holders are available in the following lengths: 6, 7, 8, 9 and 10mm. These lengths are indicated on the holders by means of a laser mark
3.3. Screw driver and flat key
The screw driver is a standard dental screwdriver that can be used to attach or remove the implant holders to/from the implants by means of screws. The flat key connects to the implant holders and can be used to provide countertorque when tightening or loosening the screw that attached the implant holder to the implant.
4. Materials
The items are made either in stainless steel (Inox: Z30C13) or Titanium (alloys) in accordance to the ISO5832 standards.
5. Cleaning
Items are cleaned in a clean room, according to NF S 90-438-1 prior to packaging
6. Packaging
Packaging of the items is done in clean and inert blisters. The drills are packaged in a sterile manner, with the lifetime mentioned on the label.
The items will be imported either separately, in combination (of at least two different items) or as a convenience kit that is marketed under the name ‘SAFE system’. In the latter case, the items are packed in a sealed milled plastic tray with individual compartments. The tray is in turn packed in a box.”
The drill bits will be used only with a specially designed dental drill and the implant holders, per your attachment, “are designed to connect with external hexagon implants with a maximal platform diameter of 4.15 mm” and “can be screwed on dental implants.”
While drill bits and holders in general have non-medical uses, these two items “are clearly identifiable for medical or surgical use” due to their unusual characteristics as required by the Harmonized System Explanatory Note to HS 90.18.
The applicable subheading for the SAFE drills will be 9018.41.0000, Harmonized Tariff Schedule of the United States (HTS), which provides for Dental drill engines…and parts and accessories thereof. The rate of duty will be free.
The applicable subheading for the SAFE implant holders will be 9018.49.8080, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” instruments and appliances, used in dental sciences, and parts and accessories thereof.
The rate of duty will be free.
The applicable subheading for the Safe System will be 9018.49.8080, Harmonized Tariff Schedule of the United States (HTS), which provides for “other” instruments and appliances, used in dental sciences, and parts and accessories thereof. The rate of duty will be free.
Regarding the SAFE Flat Key, Handpiece Connector and Manual Screw Driver, and the dozens of partial combinations of the five items you inquired about, we are returning your request for a ruling, and any related samples, exhibits, etc.
We need additional information in order to issue a ruling. Please submit:
Samples of one of each if each is under 1 pound in weight and $50 in cost.
Explain why the pictures you submitted of two quite different looking items are labeled SAFE Implant Holders. Is the picture that is so labeled on the second page actually SAFE Handpiece Connectors for Implant Holders? If not, explain the difference between the two Implant Holders.
For these three items, do you believe that they “are clearly identifiable for medical or surgical use” due to their unusual characteristics as required by the Harmonized System Explanatory Note to HS 90.18. If so, what are those characteristics, if any, for each.
Regarding the partial combinations of the five items you inquired about, state specifically which combinations you are requesting a ruling for and how they would be packed.
Please limit your ruling request to a maximum of 5 items, including combination items, of the same class or kind.
If you decide to resubmit your request, please include all of the material that we have returned to you and mail your request to U.S. Customs and Border Protection, Customs Information Exchange, 10th Floor, One Penn Plaza, New York, NY 10119, attn: Binding Rulings Section. If your request was submitted electronically and the information required does not involve sending a sample, you can re-submit your request and the additional information electronically.
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 this letter, contact National Import Specialist J. Sheridan at 646-733-3012.
Sincerely,
Robert B. Swierupski
Director,
National Commodity
Specialist Division