St Stclsr
St Stclsr is a Class II device made by Shinhung MST Co., Ltd., cleared under FDA 510(k) K221752 on 4 Jun 2023 and listed in FDA GUDID since 9 Jun 2023 (UDI-DI 08809458319212), active as of 23 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 | Number08809458319212 | Date9 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221752 | Date4 Jun 2023 | StatusActive |
Official records
- AccessGUDID record 08809458319212
- FDA 510(k) database K221752
Across registries
- FDA 510(k) K221752 decided 4 Jun 2023 Active
- FDA GUDID UDI-DI 08809458319212 listed 9 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K221752
- Listed FDA GUDID 08809458319212
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- St
- Generic name
- Dental implant suprastructure, temporary, preformed, single-use
- Model / reference
- STCLSR
- Primary DI / UDI-DI
- 08809458319212
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant suprastructure, temporary, preformed, single-use
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Dental implant suprastructure, temporary, preformed, single-use.