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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 K140537
Device Name TENURE4G
Applicant
Den-Mat Holdings, LLC
1017 W. Central Ave.
Lompoc,  CA  93436
Applicant Contact HELEN RAGUS
Correspondent
Den-Mat Holdings, LLC
1017 W. Central Ave.
Lompoc,  CA  93436
Correspondent Contact HELEN RAGUS
Regulation Number872.3200
Classification Product Code
KLE  
Date Received03/04/2014
Decision Date 08/20/2014
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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