Primodent
by Polident d.o.o. Industrija dentalnih proizvodov 803 variants
Ref PRI.41G6Model Type 1/Type 2
Active
CE MDR
Valid until
29 Jul 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberMDR-0014 | Date24 Jun 2026 | StatusActive |
Certificates
- MDR-0014 Restricted
Quality management system EU MDR
- Certifier
- SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304
- Issued
- 24 Jun 2026
- Expires
- 29 Jul 2029
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Artificial Polymer Teeth
- Model / Reference
- Type 1/Type 2, PRI.41G6
- Primary DI / UDI-DI
- +EPOLPRI41G607
- Basic UDI-DI
- ++EPOLAPTKB
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class IIa
- EU market of registration
- Slovenia
Manufacturer details
- EUDAMED SRN
- SI-MF-000000740
Other devices from Polident d.o.o. Industrija dentalnih proizvodov
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Properties
Other properties (13)
- Sterile: 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