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The Tracker / September 2026 / K262252

510(k) cleared

MPa Max adhesive

Den-Mat Holdings, LLC · Sep 24, 2026 · K262252

FDA cleared the MPa Max adhesive from Den-Mat Holdings, LLC on Sep 24, 2026 under K262252, a traditional 510(k). The device falls under product code KLE, Agent, Tooth Bonding, Resin, regulated at 21 CFR 872.3200 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 2, 2026. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Den-Mat Holdings, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262252?

K262252 is the FDA 510(k) for MPa Max adhesive, submitted by Den-Mat Holdings, LLC. FDA's decision date was Sep 24, 2026, under product code KLE (Agent, Tooth Bonding, Resin).

Who makes the MPa Max adhesive?

Den-Mat Holdings, LLC, based in Lompoc, CA, is the applicant of record for K262252.

How long did the K262252 review take?

FDA received the submission on Jul 2, 2026 and issued its decision on Sep 24, 2026, 84 days later.

← All decisions in September 2026