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ProSystem: Antirotation Castable Abutment, External Hexagon - STANDARD
EUDAMEDClass I (EU MDR)
Ref PE410
Identity
- Trade Name
- ProSystem: Antirotation Castable Abutment, External Hexagon - STANDARD EUDAMED
- Device Name
- Dental prosthetic component EUDAMED
- Model / Reference
- PE410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323034178 EUDAMED
- Basic UDI-DI
- 8050323D0019AYR EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
ProSystem: Antirotation Castable Abutment, External Hexagon - STANDARD by Permedica S.p.A — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8050323D0019AYR | Class I | Active |
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Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (1)
- EUDAMED 416f4b7b-8da7-4d53-bf37-97ee661a847d 61 fields · synced Jul 14, 2026