← Back to catalogue
ProSystem: Antirotation Castable Abutment, External Hexagon - LARGE
EUDAMEDClass I (EU MDR)
Ref PE510
Identity
- Trade Name
- ProSystem: Antirotation Castable Abutment, External Hexagon - LARGE EUDAMED
- Device Name
- Dental prosthetic component EUDAMED
- Model / Reference
- PE510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08050323034291 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 - LARGE 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Permedica S.p.A
- EUDAMED SRN
- IT-MF-000008110
Sources (1)
- EUDAMED 074b3ad3-6b6c-40b5-bb57-e9267c67de5f 61 fields · synced Jul 15, 2026