Identity
- Trade Name
- Tools FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Coated Drills EUDAMEDCoated Drill Bit FDA UDI
- Model / Reference
- TDD-2.5 EUDAMEDFDA UDI
- Description
- Coated Drill Bit FDA UDI
Identifiers
- Catalog Number
- TDD-2.5 FDA UDI
- Primary DI / UDI-DI
- 07290111274602 EUDAMEDFDA UDI
- Basic UDI-DI
- 72911127CoatedDrills9J 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
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Also classified as Fixture/appliance dental drill bit, reusable.
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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 f3ac8e1c-1108-41f5-aad3-a5fb62e20666 35 fields · synced Jun 20, 2026
- EUDAMED 7ffeed8e-2d14-433f-a238-fec6ac1b3ffd 61 fields · synced Jun 20, 2026