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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name resin, denture, relining, repairing, rebasing
510(k) Number K162572
Device Name NextDent Denture, E-Denture
Applicant
VERTEX-DENTAL BV
JOHAN VAN OLDENBARNEVELTLAAN
62
ZEIST,  NL 3705 HJ
Applicant Contact O. F. Beckeringh van Loenen
Correspondent
Qserve Group US Inc.
5600 WISCONSIN AVENUE
CHEVY CHASE,  MD  20815
Correspondent Contact Patsy J. Trisler
Regulation Number872.3760
Classification Product Code
EBI  
Date Received09/15/2016
Decision Date 06/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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