LED PRO SEAL

Coating, Filling Material, Resin

RELIANCE ORTHODONTIC PRODUCTS, INC.

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

Pre-market Notification Details

Device IDK073243
510k NumberK073243
Device Name:LED PRO SEAL
ClassificationCoating, Filling Material, Resin
Applicant RELIANCE ORTHODONTIC PRODUCTS, INC. 1540 WEST THORNDALE AVE. Itasca,  IL  60143
ContactPaul Gange
CorrespondentPaul Gange
RELIANCE ORTHODONTIC PRODUCTS, INC. 1540 WEST THORNDALE AVE. Itasca,  IL  60143
Product CodeEBD  
CFR Regulation Number872.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-19
Decision Date2008-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D798LEDPRO0 K073243 000

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