al Dente
by al dente Dentalprodukte GmbH 23 variants
Ref 02-4300
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 | Number426253316AluBiteWaxYW 04262533160163 | Date2 Jun 2025 | 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- Withdrawn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
- Alu-Bisswachs
- Model / Reference
- 02-4300
- Primary DI / UDI-DI
- 04262533160163
- Basic UDI-DI
- 426253316AluBiteWaxYW
- Direct Marketing DI
- 04262533160163
- EMDN Code
- Q01020203 Occlusal waxes
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005029
Other devices from al dente Dentalprodukte GmbH
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