Gradia Forte
510(k) K080478
Gradia Forte is a medical device (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Gc America Inc., cleared under FDA 510(k) K080478 on 5 Jun 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 | NumberK080478 | Date5 Jun 2008 | StatusActive |
Official records
- FDA 510(k) database K080478
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- Withdrawn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
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