Ultra SEP

Agent, Tooth Bonding, Resin

Reliance Orthodontic Products, Inc

The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc with the FDA for Ultra Sep.

Pre-market Notification Details

Device IDK210945
510k NumberK210945
Device Name:Ultra SEP
ClassificationAgent, Tooth Bonding, 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 CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-30
Decision Date2021-07-08

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