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510(k) K252585

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2026
Date Received
August 15, 2025
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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  • K232170 — Ti Link Abutment (January 12, 2024)
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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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