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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K132209
Device Name IPS E.MAX CAD ABUTMENT SOLUTIONS
Applicant
IVOCLAR VIVADENT AG
175 PINEVIEW DR.
AMHERST,  NY  14228
Applicant Contact DONNA HARTNETT
Correspondent
IVOCLAR VIVADENT AG
175 PINEVIEW DR.
AMHERST,  NY  14228
Correspondent Contact DONNA HARTNETT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/16/2013
Decision Date 10/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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