Description:
1. For shaping and refining endodontic access preparations
2. Safe-ended, non-cutting tip prevents penetration of the pulp chamber floor or the root canal walls
3. Tungsten Carbide
4. Shank diameter：1.6mm
5. Cutting surface length: 9 mm; total length: 21 mm 23mm 25mm 28mm
Package: 5pcs/Box
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The sale of this item may be subject to regulation by the U.S. Food & Drug Administration and state and local regulatory agencies.You can bid on this item if you are an authorized purchaser. If the item is subject to FDA regulation, We will verify your status as an authorized purchaser of this item before shipping of the item.If you have questions about legal obligations regarding sales of medical devices, you should consult with the FDA's Center for Devices and Radiological Health.
(This dental items is not meant to replace your doctor diagnostic. It is mainly for your piece of mind and comfort.)
Seller name: Dreamland Company
City, State: Beijing, China
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGS
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGS
510(K) Number: K192233
Regulation Number: 21 CFR 872.6070
Product Code: EBZ
FDA for Handpiece:
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGS
FDA for Scaler:
510(K) Number: K163414
Regulation Number: 872.4850
Product Code: ELC
FDA for Handpiece:
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGSFDA for Curing Light:
510(K) Number: K192233
Regulation Number: 21 CFR 872.6070
Product Code: EBZ
FDA for Handpiece:
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGS
FDA for Scaler:
510(K) Number: K163414
Regulation Number: 872.4850
Product Code: ELC
FDA for Handpiece:
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGSFDA for Curing Light:
510(K) Number: K192233
Regulation Number: 21 CFR 872.6070
Product Code: EBZ
FDA for Handpiece:
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGS
FDA for Scaler:
510(K) Number: K163414
Regulation Number: 872.4850
Product Code: ELC
FDA for Handpiece:
510(K) Number: K181691
Regulation Number: 872.4200
Classification Product Code: EFB
Subsequent Product Code: EGS