FDA 510(k) K262202: Cerasmart Forte
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices and labs can now order a new resin-based tooth-shade material cleared as substantially equivalent to predicate devices, expanding shade-matching options for indirect restorations.
Key points
- Device cleared under traditional 510(k) K262202 for GC America, Inc.
- Product is classified as Class 2 resin tooth-shade material under 21 CFR 872.3690 (product code EBF).
- Clearance confirms substantial equivalence but does not introduce new clinical data or unique performance claims.
- Routine addition to inventory for restorative clinicians or labs seeking additional shade options in the Cerasmart line.
Who should care
Read the original on openFDA Dental Devices
Full reporting and any paywall content live on accessdata.fda.gov. We summarize and score; we do not republish.
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