BACKGROUNDRegulatoryTier 1
FDA 510(k) K261695: Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
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 flowable resin restorative (KP-Flow) cleared via 510(k) adds another generic Class II composite option to the U.S. market; practice owners and DSO procurement teams can now evaluate it against existing flowables for cost or clinical preference without new regulatory hurdles.
Key points
- Traditional 510(k) clearance issued to Guilin Kevin Peter Technology Co., Ltd. under product code EBF (resin tooth-shade material).
- Device classified as Class 2 per 21 CFR 872.3690, confirming it meets the same substantial-equivalence standard as predicate flowables.
- Three viscosity variants (LF, MF, HF) cleared, giving clinicians a single-brand family for different clinical applications.
- No new clinical data or special controls required; standard post-market surveillance and labeling rules apply.
Who should care
OwnerDSO
Read the original on openFDA Dental Devices
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