PENCURE, MODEL VL-7

Activator, Ultraviolet, For Polymerization

J. MORITA USA, INC.

The following data is part of a premarket notification filed by J. Morita Usa, Inc. with the FDA for Pencure, Model Vl-7.

Pre-market Notification Details

Device IDK063529
510k NumberK063529
Device Name:PENCURE, MODEL VL-7
ClassificationActivator, Ultraviolet, For Polymerization
Applicant J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington,  DC  20005
ContactRobert A Silverman
CorrespondentRobert A Silverman
J. MORITA USA, INC. 1425 K STREET NW SUITE 1100 Washington,  DC  20005
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-22
Decision Date2007-01-05
Summary:summary

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