ZAROLAN, DUALAN, TITAN AND SUPERON

Material, Tooth Shade, Resin

DENT ZAR, INC.

The following data is part of a premarket notification filed by Dent Zar, Inc. with the FDA for Zarolan, Dualan, Titan And Superon.

Pre-market Notification Details

Device IDK891698
510k NumberK891698
Device Name:ZAROLAN, DUALAN, TITAN AND SUPERON
ClassificationMaterial, Tooth Shade, Resin
Applicant DENT ZAR, INC. 8721 SANTA MONICA BLVD. BOX 650 Los Angeles,  CA  90069
ContactDavid Zarotsky
CorrespondentDavid Zarotsky
DENT ZAR, INC. 8721 SANTA MONICA BLVD. BOX 650 Los Angeles,  CA  90069
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-20
Decision Date1989-06-09

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