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510(k) K211090

ZENEX Implant System by Izenimplant Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2022
Date Received
April 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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  • K231557 — ZENEX FreeMilling & CCM Cast Abutment (August 24, 2023)
  • K230630 — ZENEX Implant System_Narrow (July 31, 2023)

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