510(k) clearance
Cerasmart Forte
- 510(k) number
- K262202
- Applicant
- GC America, Inc.
- Decision date
- Sep 10, 2026
- Date received
- Jun 29, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EBF
- Device type
- Material, Tooth Shade, Resin
- Device class
- Class II
- Regulation
- 21 CFR 872.3690
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Alsip, IL, US