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Stahlbohrer
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1.204.005Model 10521Ref 1.104.018Model 17761
Identity
- Trade Name
- Stahlbohrer EUDAMEDEDENTA FDA UDI
- Generic Name
- Steel dental bur, reusable FDA UDI
- Device Name
- HM-/Stahl-Bohrer EUDAMEDPodologie Schleifer EUDAMEDSteel bur FDA UDI
- Model / Reference
- 10521 EUDAMED1.204.005 EUDAMEDFDA UDI17761 EUDAMED1.104.018 EUDAMEDFDA UDI
- Description
- Steel bur FDA UDI
Identifiers
- Catalog Number
- SB1-018HP FDA UDI
- Primary DI / UDI-DI
- E31212040051 EUDAMEDFDA UDIE31211040181 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31210521CQ EUDAMED++E31217761EX EUDAMED
- Unit of Use DI
- E3121204005101 EUDAMEDE3121104018101 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMEDZ12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Steel 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
Stahlbohrer 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 (5)
- EUDAMED 5ce2a1f6-8985-49f6-9604-4b39f49600d9 61 fields · synced Jul 16, 2026
- EUDAMED 68af6360-3f58-41fe-b3eb-0cf5becf2b7a 61 fields · synced May 18, 2026
- FDA UDI bf86305e-523f-4137-ba08-b24fc658fe1a 33 fields · synced May 29, 2026
- FDA UDI 780d78c0-081d-468d-a83d-43f14a609096 34 fields · synced May 29, 2026
- EUDAMED 3cb05f93-5095-458d-ac79-07c0b4e17b4b 61 fields · synced Jul 16, 2026