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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 K132881
Device Name Z5C
Applicant
Z-Systems AG
12264 EL CAMINO REAL
STE. 400
SAN DIEGO,  CA  92130
Applicant Contact LINDA K SCHULZ
Correspondent
Z-Systems AG
12264 EL CAMINO REAL
STE. 400
SAN DIEGO,  CA  92130
Correspondent Contact LINDA K SCHULZ
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received09/13/2013
Decision Date 07/03/2014
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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