Cerasmart Forte— 510(k) K262202
Substantially EquivalentGC America, Inc.
FDA 510(k) clearance K262202 for Cerasmart Forte, Substantially Equivalent on 2026-09-10. Applicant: GC America, Inc.. Device class: 2.
Summary
Cerasmart Forte is a new version of GC's CERASMART, a resin-based CAD/CAM block that dentists and labs mill into crowns, inlays, and onlays. It's filed under EBF, tooth shade resin materials.
Class II, 21 CFR 872.3690. The Dental panel reviewed it as a Traditional 510(k).
GC America filed from Alsip, Illinois. Review took 73 days (June 29 to September 10, 2026). "Forte" suggests a stronger formulation, but the record doesn't give material properties.
Clearance details
- Applicant
- GC America, Inc.
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alsip, IL, US
Recent devices under product code EBF
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