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Brånemark System® Mk III TiU RP 4.0x11.5mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 28921
Identity
- Trade Name
- Brånemark System® Mk III TiU RP 4.0x11.5mm EUDAMEDBrånemark System® FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Straight implants EUDAMEDBrånemark System® Mk III TiU RP 4.0x11.5mm FDA UDI
- Model / Reference
- 28921 EUDAMEDFDA UDI
- Description
- Brånemark System® Mk III TiU RP 4.0x11.5mm FDA UDI
Identifiers
- Catalog Number
- 28921 FDA UDI
- Primary DI / UDI-DI
- 07332747159547 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001266Z EUDAMED
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 11.500 Millimeter FDA UDIOuter Diameter — 4.000 Millimeter FDA UDI
Brånemark System® Mk III TiU RP 4.0x11.5mm by Nobel Biocare AB — Class IIb — 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 | 73327470000001266Z | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED c889de7b-670d-4d2d-8340-24b005bccf25 61 fields · synced Oct 6, 2026
- FDA UDI 4999cd96-8aad-42ec-90a3-eacffabe69f4 37 fields · synced May 30, 2026