IMPROVED SEQUENCE LIGHT CURE ADHESIVE

Adhesive, Bracket And Tooth Conditioner, Resin

ORMCO CORP.

The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Improved Sequence Light Cure Adhesive.

Pre-market Notification Details

Device IDK921385
510k NumberK921385
Device Name:IMPROVED SEQUENCE LIGHT CURE ADHESIVE
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
Applicant ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora,  CA  91740
ContactFrances Zee
CorrespondentFrances Zee
ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora,  CA  91740
Product CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-23
Decision Date1992-04-21

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