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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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