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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 K160798
Device Name IPS e.max® Press Abutment Solutions for Viteo Base Ti
Applicant
IVOCLAR VIVADENT AG
BENDERERSTRASSE 2
SCHAAN,  LI FL-9494
Applicant Contact Sandra Cakebread
Correspondent
IVOCLAR VIVADENT, INC.
175 PINEVIEW DRIVE
AMHERST,  NY  14228
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/23/2016
Decision Date 12/15/2016
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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