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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K262243
Device Name Profisil Free
Applicant
Kettenbach GmbH & Co. KG
Im Heerfeld 7
Eschenburg,  DE 35713
Applicant Contact Marleen Steger
Correspondent
Kettenbach GmbH & Co. KG
Im Heerfeld 7
Eschenburg,  DE 35713
Correspondent Contact Marleen Steger
Regulation Number872.3260
Classification Product Code
LBH  
Date Received07/01/2026
Decision Date 09/03/2026
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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