Nexus Universal Self-Cure

Cement, Dental

Kerr Corporation

The following data is part of a premarket notification filed by Kerr Corporation with the FDA for Nexus Universal Self-cure.

Pre-market Notification Details

Device IDK191548
510k NumberK191548
Device Name:Nexus Universal Self-Cure
ClassificationCement, Dental
Applicant Kerr Corporation 1717 W. Collins Ave Orange,  CA  92867
ContactArdrena Jackson
CorrespondentArdrena Jackson
Sybron Dental Specialties 1717 W. Collins Ave. Orange,  CA  92867
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-12
Decision Date2019-10-11
Summary:summary

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