Gradia Core
510(k) K082171
Gradia Core is a Class II device made by Gc America Inc., cleared under FDA 510(k) K082171 on 30 Oct 2008, 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 | NumberK082171 | Date30 Oct 2008 | StatusActive |
Official records
- FDA 510(k) database K082171
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- FDA applicant
- GC America, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K082171
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 | |||
|---|---|---|---|---|
| GRADIA® 003651 | 003651 / 003651 | D0470036511 | — | No longer on the market |
| GRADIA® 003651 | 003651 / 003651 | 14548161296564 | — | On the market |
| GRADIA® 003652 | 003652 / 003652 | 14548161282970 | — | On the market |
| GRADIA® 003652 | 003652 / 003652 | D0470036521 | — | On the market |
| GRADIA® 003653 | 003653 / 003653 | D0470036531 | Total Volume 3 mL | No longer on the market |
| GRADIA® 003653 | 003653 / 003653 | 14548161296571 | Total Volume 3 mL | On the market |
| GRADIA® 003654 | 003654 / 003654 | D0470036541 | Total Volume 1.5 mL | No longer on the market |
| GRADIA® 003654 | 003654 / 003654 | 14548161296588 | Total Volume 1.5 mL | On the market |
| GRADIA® 400010 | 400010 / 400010 | D6584000101 | — | On the market |
| GRADIA® 400010 | 400010 / 400010 | 10386040008471 | — | On the market |
| GRADIA® 400011 | 400011 / 400011 | 10386040008488 | — | On the market |
| GRADIA® 400011 | 400011 / 400011 | D6584000111 | — | On the market |
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