Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, reusable FDA UDI
- Device Name
- Plan Abutments EUDAMEDRC Plan screw-retained abutment, POM, angled 17°, D 4.6mm, GH 2.5mm, Type B FDA UDI
- Model / Reference
- 025.4650-04 EUDAMEDPlan Abutments FDA UDI
- Description
- RC Plan screw-retained abutment, POM, angled 17°, D 4.6mm, GH 2.5mm, Type B FDA UDI
Identifiers
- Catalog Number
- 025.4650-04 FDA UDI
- Primary DI / UDI-DI
- 07630031712400 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170007QG EUDAMED
- Unit of Use DI
- 07630031757067 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 4.6 Millimeter FDA UDIHeight — 2.5 Millimeter FDA UDIAngle — 17 degree FDA UDI
Plan Abutments is a Class IIa dental implant system from Etkon GmbH, designed for surgical placement of single and multi-unit implants. Featuring a unique endodontic disruptor design, Plan Abutments offers improved osseointegration and reduced postoperative pain.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 bd747ac5-a7e8-4908-b2d5-9b6e45ac4d71 61 fields · synced Jun 27, 2026
- FDA UDI 7b8ff1b0-bbe2-413b-b7e6-59b0fe2b6b81 37 fields · synced May 30, 2026