FDA 510(k) Application Details - K960565

Device Classification Name Material, Tooth Shade, Resin

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510(K) Number K960565
Device Name Material, Tooth Shade, Resin
Applicant DENT ZAR, INC.
6362 HOLLYWOOD BLVD., #214
LOS ANGELES, CA 90028 US
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Contact EUGENE ZAROTSKY
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Regulation Number 872.3690

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Classification Product Code EBF
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Date Received 02/09/1996
Decision Date 03/22/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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