FDA 510(k)

ICX-Implant System

K-Number: K231566 · 2024-09-05

Decision Date2024-09-05

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ICX-Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Medentis Medical GmbH. It received FDA 510(k) clearance on 2024-09-05 under 510(k) number K231566. 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 ICX-Implant System?

ICX-Implant System is a medical device that received FDA 510(k) clearance on 2024-09-05. The listed applicant is Medentis Medical GmbH. The 510(k) number is K231566.

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

ICX-Implant System received FDA 510(k) clearance on 2024-09-05, under 510(k) number K231566.

Who is the listed applicant for ICX-Implant System?

The FDA 510(k) record lists Medentis Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICX-Implant System?

The FDA product code for ICX-Implant System is DZE.

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 AB K252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

Official Source

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