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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 K191523
Device Name Visalys Restorative Primer
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 Number872.3200
Classification Product Code
KLE  
Date Received06/10/2019
Decision Date 10/09/2019
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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