Identity
- Trade Name
- Tools FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Straight Drills (Not Coated) EUDAMEDDrill Bit, 3.2 mm Diameter FDA UDI
- Model / Reference
- TD-3.2 EUDAMEDFDA UDI
- Description
- Drill Bit, 3.2 mm Diameter FDA UDI
Identifiers
- Catalog Number
- TD-3.2 FDA UDI
- Primary DI / UDI-DI
- 07290107274999 EUDAMEDFDA UDI
- Basic UDI-DI
- 72911127DrillsNotCoatRY EUDAMED
- 510(k) Number
- K132125 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Fixture/appliance dental drill bit, reusable
Tools by A.b. Dental Devices Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K132125 also covers:
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- A.b. Dental Devices Ltd
Sources (2)
- FDA UDI 99633537-c0fc-465f-b9aa-2239649b18b8 36 fields · synced Jul 31, 2026
- EUDAMED f60e9ffb-7656-404d-9602-1a2c3b2ec9dc 61 fields · synced Jul 31, 2026