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Bone Mill with Guide Brånemark System® NP Ø4.5
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 33392
Identity
- Trade Name
- Bone Mill with Guide Brånemark System® NP Ø4.5 EUDAMEDBrånemark System® FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Bone mill with guide EUDAMEDBone Mill with Guide Brånemark System® NP Ø4.5 FDA UDI
- Model / Reference
- 33392 EUDAMEDFDA UDI
- Description
- Bone Mill with Guide Brånemark System® NP Ø4.5 FDA UDI
Identifiers
- Catalog Number
- 33392 FDA UDI
- Primary DI / UDI-DI
- 07332747210262 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000014779 EUDAMED
- Direct Marketing DI
- 07332747005004 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
Dimensions & Sizes
- Size
- Outer Diameter — 4.500 Millimeter FDA UDI
Bone Mill with Guide Brånemark System® NP Ø4.5 by Nobel Biocare AB — 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 | 733274700000014779 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED e94eaa22-78e6-414f-b20d-70792184fe49 61 fields · synced Jun 20, 2026
- FDA UDI 6915217b-e2a8-4ab5-a88b-177e31c36578 37 fields · synced May 30, 2026