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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K083652
Device Name IBOND TOTAL ETCH
Applicant
Heraeus Kulzer,GmbH
4315 S Lafayette Blvd.
South Bend,  IN  46614
Applicant Contact CHERYL ZIMMERMAN
Correspondent
Heraeus Kulzer,GmbH
4315 S Lafayette Blvd.
South Bend,  IN  46614
Correspondent Contact CHERYL ZIMMERMAN
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
LBH  
Date Received12/09/2008
Decision Date 01/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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