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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K193436
Device Name VITA Ambria
Applicant
Vita Zahnfabrik GmbH H Rauter & CO
Spitelgasse 3
Bad Sackingen,  DE D-79713
Applicant Contact Bernd Walker
Correspondent
Vita North America
22705 Savi Ranch Pkwy., Suite 100
Yorba Linda,  CA  92887
Correspondent Contact Lindsay Tilton
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/11/2019
Decision Date 05/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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