Ortopoli
by Polident d.o.o. Industrija dentalnih proizvodov 14 variants
Ref 02983
Active
CE MDR
Valid until
29 Jul 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Overview
At Ortopoli, we revolutionize dental care with our innovative, Class IIa implantable device. The Polident d.o.o. Industrija dentalnih proizvodov sterilized version offers unparalleled quality and reliability in the realm of oral health.
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- Withdrawn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
- Model / Reference
- 02983
- Primary DI / UDI-DI
- +EPOL029830I
- Basic UDI-DI
- ++EPOLORTOMHA
- 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