Cytrans Granules
510(k) K192597
Cytrans Granules is a Class II device made by Gc America Inc., cleared under FDA 510(k) K192597 on 17 Aug 2020, 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 | FDA 510(k)SESE | NumberK192597 | Date17 Aug 2020 | StatusActive |
Official records
- FDA 510(k) database K192597
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LYC
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3930
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K192597
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Cytrans Granules 014360 | 014360 / 014360 | 14548161312134 | — | On the market |
| Cytrans Granules 014361 | 014361 / 014361 | 14548161312141 | — | On the market |
| Cytrans Granules 014362 | 014362 / 014362 | 14548161312158 | — | On the market |
| Cytrans Granules 014363 | 014363 / 014363 | 14548161312165 | — | On the market |
| Cytrans Granules 014364 | 014364 / 014364 | 14548161312172 | — | On the market |
| Cytrans Granules 10007516 | 014360 / 10007516 | 04548161312137 | — | No longer on the market |
| Cytrans Granules 10007516 | 014360 / 10007516 | D0470143601 | — | On the market |
| Cytrans Granules 10007517 | 014361 / 10007517 | D0470143611 | — | On the market |
| Cytrans Granules 10007517 | 014361 / 10007517 | 04548161312144 | — | No longer on the market |
| Cytrans Granules 10007518 | 014362 / 10007518 | 04548161312151 | — | No longer on the market |
| Cytrans Granules 10007518 | 014362 / 10007518 | D0470143621 | — | On the market |
| Cytrans Granules 10007519 | 014363 / 10007519 | 04548161312168 | — | No longer on the market |
| Cytrans Granules 10007519 | 014363 / 10007519 | D0470143631 | — | On the market |
| Cytrans Granules 10007520 | 014364 / 10007520 | D0470143641 | — | On the market |
| Cytrans Granules 10007520 | 014364 / 10007520 | 04548161312175 | — | No longer on the market |
| Cytrans Granules 10041295 | 10041295 / 10041295 | D047014615 | — | On the market |
| Cytrans Granules 10041295 | 10041295 / 10041295 | 14550565002269 | — | On the market |
| Cytrans Granules 10041296 | 10041296 / 10041296 | D047014616 | — | On the market |
| Cytrans Granules 10041296 | 10041296 / 10041296 | 14550565002276 | — | On the market |
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