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.

Clearance details

Applicant: NuSmile, Ltd.
Product code: 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.