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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 K153645
Device Name VITA ENAMIC Implant Solutions (IS)
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 Parkway
Suite 100
Yorba Linda,  CA  92887
Correspondent Contact NEVINE ERIAN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/21/2015
Decision Date 06/30/2016
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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