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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 K230333
Device Name Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
Applicant
Kettenbach GmbH & Co. KG
Im Heerfeld 7
Eschenburg,  DE 35713
Applicant Contact Katja Simon
Correspondent
Kettenbach GmbH & Co. KG
Im Heerfeld 7
Eschenburg,  DE 35713
Correspondent Contact Katja Simon
Regulation Number872.3260
Classification Product Code
LBH  
Date Received02/07/2023
Decision Date 07/24/2023
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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