CONTEC LIGHT

Activator, Ultraviolet, For Polymerization

DENTAURUM

The following data is part of a premarket notification filed by Dentaurum with the FDA for Contec Light.

Pre-market Notification Details

Device IDK030641
510k NumberK030641
Device Name:CONTEC LIGHT
ClassificationActivator, Ultraviolet, For Polymerization
Applicant DENTAURUM 10 PHEASANT RUN Newtown,  PA  18940
ContactJan W A. Doorschodt
CorrespondentJan W A. Doorschodt
DENTAURUM 10 PHEASANT RUN Newtown,  PA  18940
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-28
Decision Date2003-06-10

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