FDA 510(k)

ZENEX Implant System_Short

K-Number: K233163 · 2023-12-19

Decision Date2023-12-19

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ZENEX Implant System_Short is a medical device manufactured by Izenimplant Co., Ltd.. It received FDA 510(k) clearance on 2023-12-19 under approval number K233163. 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?

ZENEX Implant System_Short is a medical device that received FDA 510(k) clearance on 2023-12-19. It is manufactured by Izenimplant Co., Ltd.. The 510(k) number is K233163.

When was ZENEX Implant System_Short approved by the FDA?

ZENEX Implant System_Short received FDA 510(k) clearance on 2023-12-19, under approval number K233163.

What company makes ZENEX Implant System_Short?

ZENEX Implant System_Short is manufactured by Izenimplant Co., Ltd..

What is the FDA product code for ZENEX Implant System_Short?

The FDA product code for ZENEX Implant System_Short is DZE.

Other Devices by Izenimplant Co., Ltd.

K211090ZENEX Implant System K231557ZENEX FreeMilling & CCM Cast Abutment K230630ZENEX Implant System_Narrow K240560ZENEX Implant System_Long K232170Ti Link Abutment K253334ZENEX Implant System_Short (R-System)

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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.