Amber COLD 500 ml liquid
by Przedsiębiorstwo Usługowo Handlowe Dentex Spółka Z Ograniczoną Odpowiedzialnością
Ref DACL500XModel Cold curing denture base polymers
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number59069546ARC44 05906954695192 | Date15 Oct 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Amber Cold - Self-curing acrylic resin for the repair of dental restorations
- Model / Reference
- Cold curing denture base polymers, DACL500X
- Primary DI / UDI-DI
- 05906954695192
- Basic UDI-DI
- 59069546ARC44
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000053337
Other devices from Przedsiębiorstwo Usługowo Handlowe Dentex Spółka Z Ograniczoną Odpowiedzialnością
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