Cytrans Granules 10007519
Cytrans Granules 10007519 (014363) is a Class II device made by Gc America Inc., cleared under FDA 510(k) K192597 on 17 Aug 2020 and listed in FDA GUDID since 1 Apr 2022 (UDI-DI 04548161312168), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number04548161312168 | Date1 Apr 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192597 | Date17 Aug 2020 | StatusActive |
Official records
- AccessGUDID record 04548161312168
- FDA 510(k) database K192597
Across registries
- FDA 510(k) K192597 decided 17 Aug 2020 Active
- FDA GUDID UDI-DI 04548161312168 listed 1 Apr 2022 Listed
Timeline
- Cleared FDA 510(k) K192597
- Listed FDA GUDID 04548161312168
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cytrans Granules
- Generic name
- Dental bone void filling material, synthetic
- Model / Ref / Catalog
- 10007519, 014363
- Primary DI / UDI-DI
- 04548161312168
- 510(k) Number
- FDA product code
- LYC
- GMDN term
- Dental bone void filling material, synthetic
- Device class
- Class II
- Regulation number
- 872.3930
- GUDID distribution status
- Not in Commercial Distribution
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