DEMETRON A.2

Activator, Ultraviolet, For Polymerization

SYBRON DENTAL SPECIALTIES

The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Demetron A.2.

Pre-market Notification Details

Device IDK063116
510k NumberK063116
Device Name:DEMETRON A.2
ClassificationActivator, Ultraviolet, For Polymerization
Applicant SYBRON DENTAL SPECIALTIES 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach,  CA  92660 -8915
ContactColleen Boswell
CorrespondentColleen Boswell
SYBRON DENTAL SPECIALTIES 100 BAYVIEW CIRCLE SUITE 6000 Newport Beach,  CA  92660 -8915
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-12
Decision Date2006-12-05
Summary:summary

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