WILDE ADHESIVE BONDING SYSTEM

Agent, Tooth Bonding, Resin

WILDE-USA, INC.

The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Wilde Adhesive Bonding System.

Pre-market Notification Details

Device IDK913581
510k NumberK913581
Device Name:WILDE ADHESIVE BONDING SYSTEM
ClassificationAgent, Tooth Bonding, Resin
Applicant WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago,  IL  60608
ContactRobert W Bauer
CorrespondentRobert W Bauer
WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago,  IL  60608
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-12
Decision Date1993-02-26

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