Gc Blue Silicone
510(k) K120521
Gc Blue Silicone is a Class II device made by Gc America Inc., cleared under FDA 510(k) K120521 on 10 May 2012, 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 | NumberK120521 | Date10 May 2012 | StatusActive |
Official records
- FDA 510(k) database K120521
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ELW
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K120521
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 | |||
|---|---|---|---|---|
| FIT CHECKER™ BLUE 004905 | 004905 / 004905 | 14548161297264 | Total Volume 48 mL | On the market |
| FIT CHECKER™ BLUE 004905 | 004905 / 004905 | D0470049051 | Total Volume 48 mL | On the market |
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