HS/HG Prosthetic System SSTAN602
HS/HG Prosthetic System SSTAN602 is a Class II device made by OSSTEM IMPLANT Co., Ltd., cleared under FDA 510(k) K100245 on 17 Aug 2010 and listed in FDA GUDID since 8 Oct 2015 (UDI-DI 08800000916712), 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 | Number08800000916712 | Date8 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100245 | Date17 Aug 2010 | StatusActive |
Official records
- AccessGUDID record 08800000916712
- FDA 510(k) database K100245
Across registries
- FDA 510(k) K100245 decided 17 Aug 2010 Active
- FDA GUDID UDI-DI 08800000916712 listed 8 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K100245
- Listed FDA GUDID 08800000916712
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HS/HG Prosthetic System
- Generic name
- Dental implant suprastructure, permanent, preformed
- Model / reference
- SSTAN602
- Primary DI / UDI-DI
- 08800000916712
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant suprastructure, permanent, preformed
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization