Cerasmart Forte
FDA 510(k) K262202 · GC America, Inc.
510(k) numberK262202
Submission
- Device name
- Cerasmart Forte
- Applicant
- GC America, Inc.
Alsip, IL, US - Received
- June 29, 2026
- Decision date
- September 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cerasmart Forte cleared by the FDA?
Cerasmart Forte (K262202) received a 510(k) decision of Substantially Equivalent on September 10, 2026, 73 days after the submission was received.
What is the product code of K262202?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.