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FDA 510(k)

ZENEX Implant System_Short (R-System)

K-Number: K253334 · 2026-03-16

ApplicantIzenimplant Co., Ltd.
Decision Date2026-03-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENEX Implant System_Short (R-System) is a medical device manufactured by Izenimplant Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under approval number K253334. 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_Short (R-System)?

ZENEX Implant System_Short (R-System) is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by Izenimplant Co., Ltd.. The 510(k) number is K253334.

When was ZENEX Implant System_Short (R-System) approved by the FDA?

ZENEX Implant System_Short (R-System) received FDA 510(k) clearance on 2026-03-16, under approval number K253334.

What company makes ZENEX Implant System_Short (R-System)?

ZENEX Implant System_Short (R-System) is manufactured by Izenimplant Co., Ltd..

What is the FDA product code for ZENEX Implant System_Short (R-System)?

The FDA product code for ZENEX Implant System_Short (R-System) is DZE.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Izenimplant Co., Ltd.

K211090ZENEX Implant System K233163ZENEX Implant System_Short K231557ZENEX FreeMilling & CCM Cast Abutment K230630ZENEX Implant System_Narrow K240560ZENEX Implant System_Long K232170Ti Link Abutment

View all 8 devices →

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., 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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