FDA 510(k)

8plant Implant System

K-Number: K231426 · 2024-05-24

Decision Date2024-05-24

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

8plant Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Hoowon Edi Co., Ltd.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K231426. 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 8plant Implant System?

8plant Implant System is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Hoowon Edi Co., Ltd.. The 510(k) number is K231426.

When did 8plant Implant System receive FDA 510(k) clearance?

8plant Implant System received FDA 510(k) clearance on 2024-05-24, under 510(k) number K231426.

Who is the listed applicant for 8plant Implant System?

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

What is the FDA product code for 8plant Implant System?

The FDA product code for 8plant 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.