Identity
- Trade Name
- Bona-Bite 50ml x 32 EUDAMED
- Device Name
- Addition Curing Silicone Impression Material EUDAMED
- Model / Reference
- 210108040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05206569001310 EUDAMED
- Basic UDI-DI
- 5206569DSIL22SD EUDAMED
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Category: Silicone dental impression material
Bona-Bite 50ml x 32 by DMP Dental Industry S.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5206569DSIL22SD | Class I | Active |
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Manufacturer
- Manufacturer
- DMP Dental Industry S.A.
- EUDAMED SRN
- GR-MF-000019283
Sources (1)
- EUDAMED 0d97ee17-e687-4659-a216-9aea46625bd0 61 fields · synced Aug 2, 2026