WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX

Resin, Denture, Relining, Repairing, Rebasing

WILDE-USA, INC.

The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Wil-o-dont Orthodontic Material/wil-o-lux.

Pre-market Notification Details

Device IDK920557
510k NumberK920557
Device Name:WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX
ClassificationResin, Denture, Relining, Repairing, Rebasing
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 CodeEBI  
CFR Regulation Number872.3760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-05
Decision Date1992-03-20

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