JETLITE 4000

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 Jetlite 4000.

Pre-market Notification Details

Device IDK000078
510k NumberK000078
Device Name:JETLITE 4000
ClassificationActivator, Ultraviolet, For Polymerization
Applicant J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington,  DC  20005
ContactKeith A Barritt
CorrespondentKeith A Barritt
J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH Washington,  DC  20005
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-11
Decision Date2000-05-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.