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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 Dr.
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
Predetermined Change
Control Plan Authorized		 No
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