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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 K123278
Device Name IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
Applicant
Heraeus Kulzer, LLC
300 Heraeus Way
South Bend,  IN  46614
Applicant Contact JAMIE MEARNA
Correspondent
Heraeus Kulzer, LLC
300 Heraeus Way
South Bend,  IN  46614
Correspondent Contact JAMIE MEARNA
Regulation Number872.3200
Classification Product Code
KLE  
Date Received10/22/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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