Identity
- Trade Name
- Tools FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Class I - Dental Instruments EUDAMEDHandle FDA UDI
- Model / Reference
- T10 EUDAMEDFDA UDI
- Description
- Handle FDA UDI
Identifiers
- Catalog Number
- T10 FDA UDI
- Primary DI / UDI-DI
- 07290107274890 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
- Surgical mallet 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: Surgical mallet
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 Surgical mallet.
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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 9688d35b-92c4-421e-813c-c8b174408d7c 35 fields · synced Sep 18, 2026
- EUDAMED bffd3b3b-3ae5-4ada-bb41-5046a9fddc2b 61 fields · synced Jun 20, 2026