FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS

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 Fantastic 1 Contact Cure Orthodontic Adhesive For Plastic And Metal Brackets.

Pre-market Notification Details

Device IDK960595
510k NumberK960595
Device Name:FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS
ClassificationMaterial, Tooth Shade, Resin
Applicant DENT ZAR, INC. 19643 TRULL BROOK DR. Tarzana,  CA  91356
ContactEugene Zarotsky
CorrespondentEugene Zarotsky
DENT ZAR, INC. 19643 TRULL BROOK DR. Tarzana,  CA  91356
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-12
Decision Date1996-04-26

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