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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 K124008
Device Name IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE
Applicant
IVOCLAR VIVADENT, AGIN
175 PINEVIEW DRIVE
AMHERST,  NY  14228
Applicant Contact DONNA MARIE HARTNETT
Correspondent
IVOCLAR VIVADENT, AGIN
175 PINEVIEW DRIVE
AMHERST,  NY  14228
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/27/2012
Decision Date 03/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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