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Final Abutment:TL Abutment - Solid abut.
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 048.545
Identity
- Trade Name
- BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Final Abutment:TL Abutment ( SynOcta / Cementable / Solid abut.) EUDAMEDWN Solid Abutment 6 deg., H 4mm, green, Ti FDA UDI
- Model / Reference
- 048.545 EUDAMEDFinal Abutments FDA UDI
- Description
- WN Solid Abutment 6 deg., H 4mm, green, Ti FDA UDI
Identifiers
- Catalog Number
- 048.545 FDA UDI
- Primary DI / UDI-DI
- 07630031724946 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170006QE EUDAMED
- 510(k) Number
- K894844 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
- Models / Variants
- Solid abut. EUDAMEDFDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Angle — 6 degree FDA UDI
Final Abutment:TL Abutment - Solid abut. by Institut Straumann AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 3 models
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 | 0763003170006QE | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Institut Straumann AG
- EUDAMED SRN
- CH-MF-000009933
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (2)
- EUDAMED 42f4d4a5-36b5-4f00-8757-9a6a86b62c53 61 fields · synced Jul 18, 2026
- FDA UDI 7eb6b7f5-5f2d-439c-b14e-0b9997a9c4fd 37 fields · synced May 30, 2026