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FDA 510(k)

ZENEX Implant System_R-System

K-Number: K252585 · 2026-01-08

ApplicantIzenimplant Co., Ltd.
Decision Date2026-01-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENEX Implant System_R-System is the device name listed in this FDA 510(k) record. The listed applicant is Izenimplant Co., Ltd.. It received FDA 510(k) clearance on 2026-01-08 under 510(k) number K252585. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZENEX Implant System_R-System?

ZENEX Implant System_R-System is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is Izenimplant Co., Ltd.. The 510(k) number is K252585.

When did ZENEX Implant System_R-System receive FDA 510(k) clearance?

ZENEX Implant System_R-System received FDA 510(k) clearance on 2026-01-08, under 510(k) number K252585.

Who is the listed applicant for ZENEX Implant System_R-System?

The FDA 510(k) record lists Izenimplant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZENEX Implant System_R-System?

The FDA product code for ZENEX Implant System_R-System is DZE.

Other records listing Izenimplant Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253334ZENEX Implant System_Short (R-System)K240560ZENEX Implant System_LongK232170Ti Link AbutmentK233163ZENEX Implant System_ShortK231557ZENEX FreeMilling & CCM Cast AbutmentK230630ZENEX Implant System_Narrow

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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