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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 K191382
Device Name IPS e.max CAD Abutment Solutions- extra systems
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 Lori Aleshin
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received05/23/2019
Decision Date 08/26/2019
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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