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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 K150933
Device Name iBond Universal & iBond Ceramic Primer
Applicant
Heraeus Kulzer, LLC, Mitsui Chemicals Group
3001 Heraeus Way
South Bend,  IN  46614
Applicant Contact Jamie Cleveland
Correspondent
Heraeus Kulzer, LLC, Mitsui Chemicals Group
3001 Heraeus Way
South Bend,  IN  46614
Correspondent Contact Jamie Cleveland
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EBF  
Date Received04/06/2015
Decision Date 07/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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