Identity
- Trade Name
- Tools FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- Class I - Dental Instruments EUDAMEDRatchet Wrench FDA UDI
- Model / Reference
- T8 EUDAMEDFDA UDI
- Description
- Ratchet Wrench FDA UDI
Identifiers
- Catalog Number
- T8 FDA UDI
- Primary DI / UDI-DI
- 07290107274869 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011127TOOLSClassI3T EUDAMED
- 510(k) Number
- K132125 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
- GMDN Term
- Dental torque wrench FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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 II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental torque wrench.
- Torque Wrench Kit — Elos Medtech Pinol A/S · Class I
- Torque Wrench — Elos Medtech Pinol A/S · Class I
- Restore — Keystone Dental Inc. · Class I
- 4-Part Telescoping Herbst Replacement Parts — SPECIALTY APPLIANCES, LLC · Class I
- RS 2.45 Hex Handpiece Adapter FLX - Short — ADIN DENTAL IMPLANT SYSTEMS LTD · Class I
- 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
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
European Union Unknown
MDR
United States Pending data
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 |
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Manufacturer
- Manufacturer
- A.b. Dental Devices Ltd
Sources (2)
- FDA UDI 209f59b5-d83d-49c5-94f9-f8e2ef9849f4 36 fields · synced Jul 15, 2026
- EUDAMED b209d97f-0d04-459b-8b13-6bee3192635e 61 fields · synced Jul 15, 2026