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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 K960565
Device Name ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE
Applicant
Dent Zar, Inc.
6362 Hollywood Blvd., #214
Los Angeles,  CA  90028
Applicant Contact EUGENE ZAROTSKY
Correspondent
Dent Zar, Inc.
6362 Hollywood Blvd., #214
Los Angeles,  CA  90028
Correspondent Contact EUGENE ZAROTSKY
Regulation Number872.3690
Classification Product Code
EBF  
Date Received02/09/1996
Decision Date 03/22/1996
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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