Dental 3D Print Resin
by Tianjin Dent Technology Co., Ltd.
Ref 001AModel 015A 015B 015C 015D 015E 015F 015G 015H 015I 015J 015K 015L 015M 015N 015O 015P 015Q 015R 015S 015T 015U 015V 015W 015X 015Y 015Z 016A 016B 016C 016D 016E 016F,etc
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 | Number697864977Dent0012P 06978649770018 | Date8 May 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- Withdrawn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
- Dental 3D Print Resin
- Model / Reference
- 015A 015B 015C 015D 015E 015F 015G 015H 015I 015J 015K 015L 015M 015N 015O 015P 015Q 015R 015S 015T 015U 015V 015W 015X 015Y 015Z 016A 016B 016C 016D 016E 016F,etc, 001A
- Primary DI / UDI-DI
- 06978649770018
- Basic UDI-DI
- 697864977Dent0012P
- EMDN Code
- Q0102050101 Temporary teeth resins
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000047577
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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