BACKGROUNDRegulatoryTier 1
FDA 510(k) K253909: NeoPEX Pre-Mixed Obturation Paste
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
The 510(k) clearance of NuSmile’s NeoPEX pre-mixed obturation paste expands the material options available to general dentists and pediatric specialists for root-canal obturation, but does not introduce a novel regulatory pathway or clinical protocol.
Key points
- Device classified as Class II (regulation 872.3820) under product code KIF; marketed as substantially equivalent to predicate resin-based root-canal filling materials.
- Intended for use in permanent and primary teeth where a pre-mixed, resin-type sealer is indicated; clearance does not include new clinical performance data beyond predicate comparison.
- Cleared via the Traditional 510(k) route (K253909) on an openFDA listing; no recall or safety communication attached at time of clearance.
- Practice impact limited to inventory choice—clinicians should still follow existing obturation protocols and manufacturer IFU for mixing, placement, and setting times.
Who should care
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Read the original on openFDA Dental Devices
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