Identity
- Trade Name
- Tools FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Class I - Dental Instruments EUDAMEDRatchet Hex Driver for Abutment, 1.25 mm Diameter, 15 mm length FDA UDI
- Model / Reference
- T1-1.2,15 EUDAMEDFDA UDI
- Description
- Ratchet Hex Driver for Abutment, 1.25 mm Diameter, 15 mm length FDA UDI
Identifiers
- Catalog Number
- T1-1.2,15 FDA UDI
- Primary DI / UDI-DI
- 07290107274661 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
- Surgical screwdriver, reusable 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: Surgical screwdriver, 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 Surgical screwdriver, reusable.
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- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- A.b. Dental Devices Ltd
Sources (3)
- FDA UDI 6d287c00-710c-4517-925d-1693dc62e53e 36 fields · synced Jul 26, 2026
- EUDAMED e5bb73be-e308-4a91-8a51-33274a7df25b-1 61 fields · synced Jul 26, 2026
- EUDAMED e5bb73be-e308-4a91-8a51-33274a7df25b-2 61 fields · synced Jul 26, 2026