Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KJ ZIRCONIA Implant System

K-Number: K173116 · 2018-06-28

ApplicantKj Meditech Co., Ltd.
Decision Date2018-06-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KJ ZIRCONIA Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Kj Meditech Co., Ltd.. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K173116. 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 KJ ZIRCONIA Implant System?

KJ ZIRCONIA Implant System is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Kj Meditech Co., Ltd.. The 510(k) number is K173116.

When did KJ ZIRCONIA Implant System receive FDA 510(k) clearance?

KJ ZIRCONIA Implant System received FDA 510(k) clearance on 2018-06-28, under 510(k) number K173116.

Who is the listed applicant for KJ ZIRCONIA Implant System?

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

What is the FDA product code for KJ ZIRCONIA Implant System?

The FDA product code for KJ ZIRCONIA Implant System is DZE.

Other records listing Kj Meditech Co., Ltd. as applicant

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.

K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemK161923J2A SLA Dental Implant SystemK151970KJ Mini Implant System

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 ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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.

↑