TKO Composite Bite Turbo Gel

Material, Tooth Shade, Resin

Reliance Orthodontic Products, Inc

The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc with the FDA for Tko Composite Bite Turbo Gel.

Pre-market Notification Details

Device IDK210349
510k NumberK210349
Device Name:TKO Composite Bite Turbo Gel
ClassificationMaterial, Tooth Shade, Resin
Applicant Reliance Orthodontic Products, Inc 1540 W Thorndale Ave Itasca,  IL  60143
ContactChristine Cook
CorrespondentBrian Dean
Cook Device Solutions 7640 Delaine Ct Indianapolis,  IN  46254
Product CodeEBF  
CFR Regulation Number872.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2021-07-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D798TKOP0 K210349 000
D798TKOC0 K210349 000

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