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HM Finierer FG
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TC284K.314.014Model 10521Ref TC284K.314.016Ref TC134F.314.014
Identity
- Trade Name
- HM Finierer FG EUDAMEDEDENTA FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- HM-/Stahl-Bohrer EUDAMEDTC Finishing instruments FG FDA UDI
- Model / Reference
- 10521 EUDAMEDTC284K.314.014 EUDAMEDTC284K.314.016 EUDAMEDTC134F.314.014 EUDAMEDFDA UDI
- Description
- TC Finishing instruments FG FDA UDI
Identifiers
- Catalog Number
- H134-014F FDA UDI
- Primary DI / UDI-DI
- E312TC284K3140141 EUDAMEDE312TC284K3140161 EUDAMEDE312TC134F3140141 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31210521CQ EUDAMED
- Unit of Use DI
- E312TC284K314014101 EUDAMEDE312TC284K314016101 EUDAMEDE312TC134F314014101 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
- GMDN Term
- Carbide dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Market of Registration
- Liechtenstein 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
HM Finierer FG by Edenta Etablissement — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E31210521CQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (4)
- EUDAMED c4b2d7bb-7679-4161-8214-93c2b7306b2a 61 fields · synced Jul 25, 2026
- EUDAMED d75b5e60-a9ac-4445-956e-06cc534d5b97 61 fields · synced May 17, 2026
- EUDAMED 88e7cb8d-0465-42ee-92ab-1e937c09e6a9 61 fields · synced May 18, 2026
- FDA UDI 46980073-ed82-4b3a-aae1-8f13d92f77b8 34 fields · synced May 30, 2026