REALSEAL XT SEALER

Resin, Root Canal Filling

KERR CORPORATION

The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Realseal Xt Sealer.

Pre-market Notification Details

Device IDK102163
510k NumberK102163
Device Name:REALSEAL XT SEALER
ClassificationResin, Root Canal Filling
Applicant KERR CORPORATION 1717 WEST COLLINS AVENUE Orange,  CA  92867
ContactWendy Garmen
CorrespondentWendy Garmen
KERR CORPORATION 1717 WEST COLLINS AVENUE Orange,  CA  92867
Product CodeKIF  
CFR Regulation Number872.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-02
Decision Date2010-10-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.