GLUMA DESENSITIZER POWER GEL

Varnish, Cavity

HERAEUS KULZER, LLC

The following data is part of a premarket notification filed by Heraeus Kulzer, Llc with the FDA for Gluma Desensitizer Power Gel.

Pre-market Notification Details

Device IDK093575
510k NumberK093575
Device Name:GLUMA DESENSITIZER POWER GEL
ClassificationVarnish, Cavity
Applicant HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend,  IN  46614
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
HERAEUS KULZER, LLC 300 HERAEUS WAY South Bend,  IN  46614
Product CodeLBH  
CFR Regulation Number872.3260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-18
Decision Date2010-03-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014660434510 K093575 000

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