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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 K263680
Device Name One Coat Bond; One Coat Bond SL
Applicant
Dent4You AG
Bahnhofstrasse 2
Heerbrugg,  CH 9435
Applicant Contact Oliver Ashe
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/07/2026
Decision Date 10/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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