FDA 510(k) K262681: NanoCeram 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
For labs and practices that reline or repair dentures in-house, this new 510(k) clearance introduces another Class II relining resin option; owners should watch pricing and handling characteristics before adding to inventory.
Key points
- Clearance K262681 issued to 3BFAB TEKNOLOJI A.S. under traditional 510(k) pathway for NanoCeram Resin (denture relining, repairing, rebasing).
- Device classified as Class 2 (regulation 872.3760, product code EBI) and deemed substantially equivalent to predicate devices.
- Product adds a nano-ceramic–based option to the existing pool of reline/repair resins available to dental labs and clinics.
- No recall or safety alert accompanies this clearance; practices should still verify compatibility with existing workflow and materials.
Who should care
Read the original on openFDA Dental Devices
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