GingiKnit+, GingiBraid+, And Shortcut With GingiBraid+ Non-Impregnated Retraction Cord

Cord, Retraction

KERR CORPORATION

The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Gingiknit+, Gingibraid+, And Shortcut With Gingibraid+ Non-impregnated Retraction Cord.

Pre-market Notification Details

Device IDK162164
510k NumberK162164
Device Name:GingiKnit+, GingiBraid+, And Shortcut With GingiBraid+ Non-Impregnated Retraction Cord
ClassificationCord, Retraction
Applicant KERR CORPORATION 1717 W. COLLINS AVE Orange,  CA  92867
ContactMohammad Saad Ansari
CorrespondentMohammad Saad Ansari
SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVE Orange,  CA  92867
Product CodeMVL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-03
Decision Date2017-01-13
Summary:summary

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