Polystar Selection EDITION anteriors - mould CS2
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD7091981544 | Date31 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030588 | Date7 May 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Polystar Selection EDITION
- Generic name
- Resin artificial teeth
- Model / Ref / Catalog
- anteriors, shade A2 light, mould CS2, 1981544
- Primary DI / UDI-DI
- D7091981544
- 510(k) Number
- FDA product code
- ELM
- GMDN term
- Resin artificial teeth
- Models / Variants
- mould CS2
- Device class
- Class II
- Regulation number
- 872.3590
- GUDID distribution status
- In Commercial Distribution
Other devices from Merz Dental GmbH
Properties
Other properties (13)
- Supplied sterile: No
- Sterilise before use: No
- Single use: No
- Implantable: No
- Contains latex: No
- Prescription use: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Manufacturing date: No