HKBOND 2006

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 Hkbond 2006.

Pre-market Notification Details

Device IDK063062
510k NumberK063062
Device Name:HKBOND 2006
ClassificationAgent, Tooth Bonding, Resin
Applicant HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614
ContactCheryl V Zimmerman
CorrespondentCheryl V Zimmerman
HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend,  IN  46614
Product CodeKLE  
CFR Regulation Number872.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-10-05
Decision Date2006-12-01

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