MEDIUMRegulatoryTier 1
FDA 510(k) K262243: Profisil Free
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 gain another Class II cavity varnish option for remineralization and sensitivity; owners should review pricing and clinical performance before swapping from current suppliers.
Key points
- Kettenbach GmbH & Co. KG received 510(k) clearance for Profisil Free under product code LBH (varnish, cavity) via Traditional pathway.
- Product classified as Class II device per 21 CFR 872.3260; clearance confirms substantial equivalence to predicate varnishes.
- Clinicians may now evaluate fluoride-free formulation for patients seeking non-fluoride desensitizing or remineralization therapies.
- No change to existing regulatory burden—standard 510(k) clearance does not alter billing codes or Medicaid coverage.
Who should care
OwnerAssociate
Read the original on openFDA Dental Devices
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