Glass-FX Micro GFX-MIC
Glass-FX Micro GFX-MIC is a Class II device made by Dsi Dental Solutions, Ltd., cleared under FDA 510(k) K200555 on 13 May 2021 and listed in FDA GUDID since 15 Feb 2023 (UDI-DI D9560GFXMIC0), 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 | NumberD9560GFXMIC0 | Date15 Feb 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200555 | Date13 May 2021 | StatusActive |
Official records
- FDA 510(k) database K200555
Across registries
- FDA 510(k) K200555 decided 13 May 2021 Active
- FDA GUDID UDI-DI D9560GFXMIC0 listed 15 Feb 2023 Listed
Timeline
- Cleared FDA 510(k) K200555
- Listed FDA GUDID D9560GFXMIC0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Glass-FX Micro
- Generic name
- Glass ionomer dental cement
- Model / reference
- GFX-MIC
- Primary DI / UDI-DI
- D9560GFXMIC0
- 510(k) Number
- FDA product code
- EMA
- GMDN term
- Glass ionomer dental cement
- Device class
- Class II
- Regulation number
- 872.3275
- GUDID distribution status
- In Commercial Distribution
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