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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K152373
Device Name VITA VM LC Flow
Applicant
Vita Zahnfabrik H.Rauter GmbH & Co.
Spitelgasse 3
Bad Sackingen,  DE D-79713
Applicant Contact Bernd Walker
Correspondent
Vita North America, Inc.
22705 Savi Ranch Pkwy., Suite 100
Yorba Linda,  CA  92887
Correspondent Contact Nevine Erian
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/21/2015
Decision Date 12/30/2015
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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