FDA 510(k) K261626: UltraPrint Flexible Denture UV
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
A new flexible-denture UV resin from Guangzhou Heygears has cleared the FDA, giving practice owners and labs another Class II option for denture relining, repair, and rebasing that may affect material cost and supplier negotiations.
Key points
- Product code EBI, 510(k) K261626, cleared under traditional pathway as substantially equivalent to existing predicate devices.
- Regulation 872.3760 covers denture resins used for relining, repairing, or rebasing; this clearance adds a flexible UV-cured option to the market.
- Guangzhou Heygears IMC., Inc. is the manufacturer; clinics and DSO procurement teams can now evaluate pricing and availability versus current suppliers.
- Device class 2 status means standard FDA post-market surveillance applies—no new compliance burden beyond existing resin-handling protocols.
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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