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FDA 510(k) Application Details - K150021
Device Classification Name
Implant, Endosseous, Root-Form
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510(K) Number
K150021
Device Name
Implant, Endosseous, Root-Form
Applicant
Z-Systems AG
Bittertenstrasse 15
Oensingen 4702 CH
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Contact
Thomas Hug
Other 510(k) Applications for this Contact
Regulation Number
872.3640
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Classification Product Code
DZE
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More FDA Info for this Product Code
Date Received
01/06/2015
Decision Date
07/31/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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