FDA 510(k) K261888: ClearClub Impression Material
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
Routine 510(k) clearance of an OTC impression material for patient-matched mouthguards adds another low-risk option for practices that dispense athletic or night guards without chairside fabrication.
Key points
- Product: ClearClub Impression Material; 510(k) K261888; Class II device under 21 CFR 872.3660 (product code SHI).
- Indication limited to over-the-counter impression material for fabrication of patient-matched mouthguards.
- Traditional substantial-equivalence pathway used—no new clinical data required beyond predicate comparison.
- Does not alter in-office material workflows or billing codes for custom laboratory-fabricated guards.
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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