NeoPEX Pre-Mixed Obturation Paste— 510(k) K253909

Name: FDA 510(k) clearance K253909
Creator: U.S. Food and Drug Administration
Published: 2026-09-04

Substantially Equivalent

NuSmile, Ltd.

FDA 510(k) clearance K253909 for NeoPEX Pre-Mixed Obturation Paste, Substantially Equivalent on 2026-09-04. Applicant: NuSmile, Ltd.. Device class: 2.

Summary

NeoPEX Pre-Mixed Obturation Paste from NuSmile is filed under KIF, root canal filling resins. The record doesn't give its composition.

Class II, 21 CFR 872.3820. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).

NuSmile filed from Houston, Texas. The decision came 270 calendar days after FDA received it (December 8, 2025 to September 4, 2026).

Clearance details

Applicant: NuSmile, Ltd.
Product code: Product code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2025-12-08
Decision date: 2026-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.