TRANSLUX POWER BLUE

Activator, Ultraviolet, For Polymerization

HERAEUS KULZER GMBH

The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Translux Power Blue.

Pre-market Notification Details

Device IDK042199
510k NumberK042199
Device Name:TRANSLUX POWER BLUE
ClassificationActivator, Ultraviolet, For Polymerization
Applicant HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-08-13
Decision Date2004-09-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014660550130 K042199 000
J014660550120 K042199 000
J014660175070 K042199 000

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