Identity
- Trade Name
- American Dental Implant FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- 6mm Trephine Drill FDA UDI
- Model / Reference
- TD60 FDA UDI
- Description
- 6mm Trephine Drill FDA UDI
Identifiers
- Catalog Number
- TD60 FDA UDI
- Primary DI / UDI-DI
- D896TD600 FDA UDI
- 510(k) Number
- K945706 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fixture/appliance dental drill bit, reusable
American Dental Implant by American Dental Implant Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Bone Compaction Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Prima Plus — Keystone Dental Inc. · Class I
- FTN Tapered Drill — DIO Corporation · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
Cleared under the same submission
K945706 also covers:
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
- American Dental Implant — AMERICAN DENTAL IMPLANT CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- American Dental Implant Corporation
Sources (1)
- FDA UDI 596cc218-ca3f-4a3b-ab48-dba21c682446 37 fields · synced May 30, 2026