G-Coat
510(k) K052462
G-Coat is a Class II device made by Gc America Inc., cleared under FDA 510(k) K052462 on 20 Oct 2005, 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 | NumberK052462 | Date20 Oct 2005 | StatusActive |
Official records
- FDA 510(k) database K052462
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBD
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3310
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K052462
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 | |||
|---|---|---|---|---|
| G-COAT PLUS™ 002583 | 002583 / 002583 | D0470025831 | Total Volume 4 mL | On the market |
| G-COAT PLUS™ 002583 | 002583 / 002583 | 14548161293846 | Total Volume 4 mL | On the market |
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