J2A Dental Implant System, J2C Dental Implant System— 510(k) K150060

Name: FDA 510(k) clearance K150060
Creator: U.S. Food and Drug Administration
Published: 2015-04-02

Substantially Equivalent

Kj Meditech Co., Ltd.

FDA 510(k) clearance K150060 for J2A Dental Implant System, J2C Dental Implant System, Substantially Equivalent on 2015-04-02. Applicant: Kj Meditech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kj Meditech Co., Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2015-01-13
Decision date: 2015-04-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Gwang-Ju, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

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K202046 — LOTA SLA Dental Implant System and LOTA HA Dental Implant System2022-03-01
K173116 — KJ ZIRCONIA Implant System2018-06-28
K161923 — J2A SLA Dental Implant System2017-11-09
K151970 — KJ Mini Implant System2016-10-21
K140051 — KJ EXTERNAL IMPLANT SYSTEM2014-10-30

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.