IBOND TOTAL ETCH

Agent, Tooth Bonding, Resin

HERAEUS KULZER GMBH

The following data is part of a premarket notification filed by Heraeus Kulzer Gmbh with the FDA for Ibond Total Etch.

Pre-market Notification Details

Device IDK083652
510k NumberK083652
Device Name:IBOND TOTAL ETCH
ClassificationAgent, Tooth Bonding, Resin
Applicant HERAEUS KULZER GMBH 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614 -2517
ContactCheryl Zimmerman
CorrespondentCheryl Zimmerman
HERAEUS KULZER GMBH 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 Received2008-12-09
Decision Date2009-01-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
J014660482620 K083652 000
J014660400940 K083652 000
J014660400930 K083652 000
J014660398700 K083652 000
J014660398670 K083652 000
J014660398660 K083652 000

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