Polystar Selection EDITION anteriors - Polystar Selection EDITION anteriors
Polystar Selection EDITION anteriors - Polystar Selection EDITION anteriors is a Class II device made by Merz Dental GmbH, cleared under FDA 510(k) K030588 on 7 May 2003 and listed in FDA GUDID since 1 Oct 2017 (UDI-DI D7091981721), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD7091981721 | Date1 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK030588 | Date7 May 2003 | StatusActive |
Official records
- FDA 510(k) database K030588
Across registries
- FDA 510(k) K030588 decided 7 May 2003 Active
- FDA GUDID UDI-DI D7091981721 listed 1 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K030588
- Listed FDA GUDID D7091981721
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- Withdrawn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 D4, mould UM8, 1981721
- Primary DI / UDI-DI
- D7091981721
- 510(k) Number
- FDA product code
- ELM
- GMDN term
- Resin artificial teeth
- Device class
- Class II
- Regulation number
- 872.3590
- GUDID distribution status
- In Commercial Distribution