Nexus Universal, Nexus Universal Chroma

Cement, Dental

SYBRON DENTAL SPECIALTIES

The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Nexus Universal, Nexus Universal Chroma.

Pre-market Notification Details

Device IDK151332
510k NumberK151332
Device Name:Nexus Universal, Nexus Universal Chroma
ClassificationCement, Dental
Applicant SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange,  CA  92867
ContactCourtney Clark
CorrespondentCourtney Clark
SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange,  CA  92867
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-19
Decision Date2015-08-17
Summary:summary

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