Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Plan Abutments EUDAMEDRC PLAN Cementable Abutment, D 5mm, GH 1mm, AH 4mm, POM FDA UDI
- Model / Reference
- 025.4621-04 EUDAMEDPlan Abutments FDA UDI
- Description
- RC PLAN Cementable Abutment, D 5mm, GH 1mm, AH 4mm, POM FDA UDI
Identifiers
- Catalog Number
- 025.4621-04 FDA UDI
- Primary DI / UDI-DI
- 07630031712189 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170007QG EUDAMED
- Unit of Use DI
- 07630031756855 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDIHeight — 1 Millimeter FDA UDIHeight — 4 Millimeter FDA UDI
Plan Abutments 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 | 0763003170007QG | 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 ccf3e0e9-ffd6-4a35-b385-703e4be26cdb 61 fields · synced Jun 19, 2026
- FDA UDI f79f62d3-3bbb-4fd9-ba0b-3bca19348c4c 37 fields · synced May 30, 2026