GLUMA DESENSITIZER/GLUMA 3 PRIMER

Agent, Tooth Bonding, Resin

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Gluma Desensitizer/gluma 3 Primer.

Pre-market Notification Details

Device IDK962812
510k NumberK962812
Device Name:GLUMA DESENSITIZER/GLUMA 3 PRIMER
ClassificationAgent, Tooth Bonding, Resin
Applicant HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCherly V Zimmerman
CorrespondentCherly V Zimmerman
HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-07-18
Decision Date1996-10-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014660182210 K962812 000
J014660018540 K962812 000
J014658723540 K962812 000

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