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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K960600
Device Name LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS
Applicant
Dent Zar, Inc.
19643 Trull Brook Dr.
Tarzana,  CA  91356
Applicant Contact EUGENE ZAROTSKY
Correspondent
Dent Zar, Inc.
19643 Trull Brook Dr.
Tarzana,  CA  91356
Correspondent Contact EUGENE ZAROTSKY
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/12/1996
Decision Date 04/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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