PHASE II ORTHODONTIC ADHESIVE

Adhesive, Bracket And Tooth Conditioner, Resin

RELIANCE ORTHODONTIC PRODUCTS, INC.

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

Pre-market Notification Details

Device IDK895523
510k NumberK895523
Device Name:PHASE II ORTHODONTIC ADHESIVE
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
Applicant RELIANCE ORTHODONTIC PRODUCTS, INC. P.O. BOX 678 Itasca,  IL  60143
ContactPaul A Gange
CorrespondentPaul A Gange
RELIANCE ORTHODONTIC PRODUCTS, INC. P.O. BOX 678 Itasca,  IL  60143
Product CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-12
Decision Date1989-12-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D798PJAF0 K895523 000
D798PJA0 K895523 000
D798PESF0 K895523 000
D798PEJF0 K895523 000
D7981PSAF0 K895523 000
D7981PSA0 K895523 000

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