POLY-CARB

Crown And Bridge, Temporary, Resin

INOVATIV, LLC

The following data is part of a premarket notification filed by Inovativ, Llc with the FDA for Poly-carb.

Pre-market Notification Details

Device IDK022030
510k NumberK022030
Device Name:POLY-CARB
ClassificationCrown And Bridge, Temporary, Resin
Applicant INOVATIV, LLC 1155 TWIN HILLS DR. Jefferson,  OR  97352
ContactRobert Bowers
CorrespondentRobert Bowers
INOVATIV, LLC 1155 TWIN HILLS DR. Jefferson,  OR  97352
Product CodeEBG  
CFR Regulation Number872.3770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-21
Decision Date2002-08-28
Summary:summary

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