Cleared Traditional

els unibond

K252151 · Saremco Dental AG · Dental
Dec 2025
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K252151 is an FDA 510(k) clearance for the els unibond, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Saremco Dental AG (Rebstein, CH). The FDA issued a Cleared decision on December 5, 2025, 149 days after receiving the submission on July 9, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K252151 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2025
Decision Date December 05, 2025
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200

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