Dsi SBA5
Dsi SBA5 is a Class II device made by Dsi Dental Solutions, Ltd., cleared under FDA 510(k) K200188 on 1 Apr 2020 and listed in FDA GUDID since 27 Apr 2021 (UDI-DI D9560000SBA5), 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 | NumberD9560000SBA5 | Date27 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200188 | Date1 Apr 2020 | StatusActive |
Official records
- FDA 510(k) database K200188
Across registries
- FDA 510(k) K200188 decided 1 Apr 2020 Active
- FDA GUDID UDI-DI D9560000SBA5 listed 27 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K200188
- Listed FDA GUDID D9560000SBA5
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dsi
- Generic name
- Dental implant system
- Model / reference
- SBA5
- Primary DI / UDI-DI
- D9560000SBA5
- 510(k) Number
- FDA product code
- NHA
- GMDN term
- Dental implant system
- Device class
- Class II
- Regulation number
- 872.3630
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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