Identity
- Trade Name
- Tools FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Class I - Dental Instruments EUDAMEDRatchet-Torque Combination FDA UDI
- Model / Reference
- T8c-10-40 EUDAMEDFDA UDI
- Description
- Ratchet-Torque Combination FDA UDI
Identifiers
- Catalog Number
- T8c-10-40 FDA UDI
- Primary DI / UDI-DI
- 07290107274876 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011127TOOLSClassI3T EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
- GMDN Term
- Dental torque wrench FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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: Dental torque wrench
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 Dental torque wrench.
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- Azure — TERRATS MEDICAL SL. · Class I
- Graduated Torque Wrench — Sterngold Dental LLC · Class I
- SURGICAL TORQUE RATCHET — S.I.N. - Sistema DE Implante Nacional S.A. · 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 46c5ec2f-bec6-40ee-9902-8507499fc671 35 fields · synced Jun 19, 2026
- EUDAMED e2d3949d-0b59-47f5-b750-1fa90e2f7aba 61 fields · synced Jun 19, 2026