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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 K152243
Device Name One Coat 7 Universal
Applicant
Coltene/Whaledent AG
Feldwiesentr.20
Altstatten,  CH 9450
Applicant Contact Silke Wallaschek
Correspondent
Coltene/Whaledent AG
Feldwiesentr.20
Altstatten,  CH 9450
Correspondent Contact Silke Wallaschek
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/10/2015
Decision Date 12/09/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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