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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 K151564
Device Name Telio CAD Abutment Solutions
Applicant
IVOCLAR VIVADENT AG
BENDERERSTRASSE 2
SCHAAN,  LI 9494
Applicant Contact SANDRA CAKEBREAD
Correspondent
IVOCLAR VIVADENT, INC.
175 PINEVIEW DRIVE
AMHERST,  NY  14228
Correspondent Contact DONNA HARTNETT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/10/2015
Decision Date 09/21/2015
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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