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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 K891698
Device Name ZAROLAN, DUALAN, TITAN AND SUPERON
Applicant
Dent Zar, Inc.
8721 Santa Monica Blvd.
Box 650
Los Angeles,  CA  90069
Applicant Contact DAVID ZAROTSKY
Correspondent
Dent Zar, Inc.
8721 Santa Monica Blvd.
Box 650
Los Angeles,  CA  90069
Correspondent Contact DAVID ZAROTSKY
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/20/1989
Decision Date 06/09/1989
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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