510(k) clearance

MPa Max adhesive

FDA 510(k) source

510(k) number

K262252

Applicant

Den-Mat Holdings, LLC

Decision date

Sep 24, 2026

Date received

Jul 2, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KLE

Device type

Agent, Tooth Bonding, Resin

Device class

Class II

Regulation

21 CFR 872.3200

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Lompoc, CA, US