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The Tracker / December 2025 / K252151

510(k) cleared

els unibond

Saremco Dental AG · Dec 5, 2025 · K252151

FDA cleared the els unibond from Saremco Dental AG on Dec 5, 2025 under K252151, 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 9, 2025. The decision came 149 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Saremco Dental AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252151?

K252151 is the FDA 510(k) for els unibond, submitted by Saremco Dental AG. FDA's decision date was Dec 5, 2025, under product code KLE (Agent, Tooth Bonding, Resin).

Who makes the els unibond?

Saremco Dental AG, based in Rebstein, is the applicant of record for K252151.

How long did the K252151 review take?

FDA received the submission on Jul 9, 2025 and issued its decision on Dec 5, 2025, 149 days later.

← All decisions in December 2025