BACKGROUNDRegulatoryTier 1
FDA 510(k) K261802: Glidewell Denture Base Resin
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
Practice owners and lab managers should note that a new PMMA denture-base resin from Glidewell now has FDA clearance, widening vendor choice for in-house or outsourced denture fabrication.
Key points
- Device cleared via 510(k) K261802 on traditional pathway for denture relining, repairing, and rebasing.
- Product code EBI, Class II, under 21 CFR 872.3760; substantially equivalent to prior PMMA resins.
- Cleared for Glidewell (Prismatik Dentalcraft, Inc.)—adds another large-lab option alongside existing resin suppliers.
- No new clinical data required; equivalence means standard handling, finishing, and polishing protocols remain unchanged.
Who should care
OwnerDSOStaff
Read the original on openFDA Dental Devices
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