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HM Bohrer FGL - Kronentrenner
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C4AKXL.315.014Model 10521
Identity
- Trade Name
- HM Bohrer FGL - Kronentrenner EUDAMEDEDENTA FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- HM-/Stahl-Bohrer EUDAMEDTC Bur FGL - crown separator FDA UDI
- Model / Reference
- 10521 EUDAMEDC4AKXL.315.014 EUDAMEDFDA UDI
- Description
- TC Bur FGL - crown separator FDA UDI
Identifiers
- Primary DI / UDI-DI
- E312C4AKXL3150141 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31210521CQ EUDAMED
- Unit of Use DI
- E312C4AKXL315014101 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 Bohrer FGL - Kronentrenner 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 (2)
- EUDAMED ba776cd1-2309-4891-b144-475056f1e75f 61 fields · synced Jun 19, 2026
- FDA UDI 7d4098f6-bd89-4d63-a06a-b7051f27a33d 33 fields · synced May 30, 2026