Identity
- Trade Name
- Tools FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Straight Drills (Not Coated) EUDAMEDShort Drill Bit FDA UDI
- Model / Reference
- TDS-3.2 EUDAMEDFDA UDI
- Description
- Short Drill Bit FDA UDI
Identifiers
- Catalog Number
- TDS-3.2 FDA UDI
- Primary DI / UDI-DI
- 07290107275163 EUDAMEDFDA UDI
- Basic UDI-DI
- 72911127DrillsNotCoatRY EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fixture/appliance dental drill bit, reusable
Tools by A.b. Dental Devices Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
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- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- A.b. Dental Devices Ltd
Sources (2)
- FDA UDI 4c042a26-0b56-4800-a775-36c345a2495c 35 fields · synced Jul 9, 2026
- EUDAMED d339d012-6935-41a2-a70f-a2026d521301 61 fields · synced Jul 9, 2026