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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, root-form
510(k) Number K150021
Device Name Z5m(t)
Applicant
Z-Systems AG
Bittertenstrasse 15
oensingen,  CH 4702
Applicant Contact thomas hug
Correspondent
PaxMed International, LLC
12264 El Camino Real, Suite 400
san diego,  CA  92130
Correspondent Contact linda k. schulz
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/06/2015
Decision Date 07/31/2015
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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