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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K252151
Device Name els unibond
Applicant
Saremco Dental AG
Gewerbestrasse 4
Rebstein,  CH CH-9445
Applicant Contact Christoph Evers
Correspondent
Bqc Consulting, LLC
24341 Barbados Dr.
Dana Point,  CA  92629
Correspondent Contact Nevine Erian
Regulation Number872.3200
Classification Product Code
KLE  
Date Received07/09/2025
Decision Date 12/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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