RELI-ON ONE STEP, ORTHODONTIC ADHESIVE

Adhesive, Bracket And Tooth Conditioner, Resin

CLASSONE ORTHODONTICS, INC.

The following data is part of a premarket notification filed by Classone Orthodontics, Inc. with the FDA for Reli-on One Step, Orthodontic Adhesive.

Pre-market Notification Details

Device IDK053379
510k NumberK053379
Device Name:RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
Applicant CLASSONE ORTHODONTICS, INC. 5064 50TH ST. Lubbock,  TX  79414
ContactJudy Ribordy
CorrespondentJudy Ribordy
CLASSONE ORTHODONTICS, INC. 5064 50TH ST. Lubbock,  TX  79414
Product CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-05
Decision Date2006-01-25
Summary:summary

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