Identity
- Trade Name
- STRAUMANN MAGELLAN ABUTMENT,PROTECTIVE CAP,TITANIUM - GOLD COPINGS, BASAL SCREW FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Final Coping: Variobase Coping EUDAMEDVariobase® for Bridge/Bar Cylindrical Coping H 4mm, f. Ø 4.6mm Screw-ret. Abut., incl. screw & CA3, TAN/POM FDA UDI
- Model / Reference
- 023.0028 EUDAMEDFinal Abutments FDA UDI
- Description
- Variobase® for Bridge/Bar Cylindrical Coping H 4mm, f. Ø 4.6mm Screw-ret. Abut., incl. screw & CA3, TAN/POM FDA UDI
Identifiers
- Catalog Number
- 023.0028 FDA UDI
- Primary DI / UDI-DI
- 07630031737182 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170098RD EUDAMED
- 510(k) Number
- K133421 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 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
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.6 Millimeter FDA UDIHeight — 4 Millimeter FDA UDI
Final Coping: Variobase Coping by Institut Straumann AG — 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 | 0763003170098RD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 f0a0272c-2ca3-4c8e-adc5-c8d32ab0c185 61 fields · synced Aug 2, 2026
- FDA UDI 304de3d2-cf41-410e-9038-1111444bcab8 38 fields · synced May 30, 2026