KULZER TRANSLUX VISIBLE LIGHT CURING

Activator, Ultraviolet, For Polymerization

KULZER, INC.

The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Kulzer Translux Visible Light Curing.

Pre-market Notification Details

Device IDK811668
510k NumberK811668
Device Name:KULZER TRANSLUX VISIBLE LIGHT CURING
ClassificationActivator, Ultraviolet, For Polymerization
Applicant KULZER, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-15
Decision Date1981-07-28

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