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510(k) K233163

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2023
Date Received
September 27, 2023
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

Other clearances by Izenimplant Co., Ltd.

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  • K231557 — ZENEX FreeMilling & CCM Cast Abutment (August 24, 2023)
  • K230630 — ZENEX Implant System_Narrow (July 31, 2023)
  • K211090 — ZENEX Implant System (April 13, 2022)

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