FDA 510(k)

Jplant

K-Number: K211978 · 2022-01-05

Decision Date2022-01-05

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Jplant is the device name listed in this FDA 510(k) record. The listed applicant is Jj Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-01-05 under 510(k) number K211978. 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 Jplant?

Jplant is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Jj Medical Co., Ltd.. The 510(k) number is K211978.

When did Jplant receive FDA 510(k) clearance?

Jplant received FDA 510(k) clearance on 2022-01-05, under 510(k) number K211978.

Who is the listed applicant for Jplant?

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

What is the FDA product code for Jplant?

The FDA product code for Jplant 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.