PRIME SM Ø 3, 8 h 8, 5 con MONCONE DIRITTO SM Ø 3, 6 ht 1, 5 hc 8
Ref 0801300MF
Active
CE MDR
Valid until
26 Sep 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805214171100B019C 08052141714683 | Date18 May 2026 | StatusActive |
Certificates
- 0425-MDR-030042-04 Active
Quality management system EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 20 Jun 2025
- Expires
- 26 Sep 2028
- 0425-MDR-030042-04 Active
Quality management system EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 20 Jun 2026
- Expires
- 26 Sep 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Impianti Dentali Endossei con Componente Protesica / Dental endosseous implants with Prosthetic Component
- Model / Reference
- 0801300MF
- Primary DI / UDI-DI
- 08052141714683
- Basic UDI-DI
- 805214171100B019C
- EMDN Code
- P01020101 Dental implants
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000022007
Other devices from Prodent Italia S.r.l.
Properties
Other properties (11)
- 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