COMPATIT R

Denture, Plastic, Teeth

WILDE-USA, INC.

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

Pre-market Notification Details

Device IDK913582
510k NumberK913582
Device Name:COMPATIT R
ClassificationDenture, Plastic, Teeth
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 CodeELM  
CFR Regulation Number872.3590 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-12
Decision Date1993-06-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.