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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
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