510(k) clearance

NeoPEX™ Pre-Mixed Obturation Paste

FDA 510(k) source

510(k) number

K253909

Applicant

NuSmile, Ltd.

Decision date

Sep 4, 2026

Date received

Dec 8, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KIF

Device type

Resin, Root Canal Filling

Device class

Class II

Regulation

21 CFR 872.3820

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Houston, TX, US