Medical Device Manufacturer · US , Fullerton , CA

Kj Meditech Co., Ltd.

12 submissions · 12 cleared · Since 2011
12
Total
12
Cleared
0
Denied

Kj Meditech Co., Ltd. — FDA 510(k) Submissions

Kj Meditech Co., Ltd. has submitted 12 FDA 510(k) premarket notifications since 2011, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Headgear, Extraoral, Orthodontic, Abutment, Implant, Dental, Endosseous . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
LOTA SLA Dental Implant System and LOTA HA Dental Implant System
K202046 · DZE Implant, Endosseous,... · Dental
Mar 2022 586d
KJ ZIRCONIA Implant System
K173116 · DZE Implant, Endosseous,... · Dental
Jun 2018 272d
J2A SLA Dental Implant System
K161923 · DZE Implant, Endosseous,... · Dental
Nov 2017 484d
KJ Mini Implant System
K151970 · DZE Implant, Endosseous,... · Dental
Oct 2016 463d
J2A Dental Implant System, J2C Dental Implant System
K150060 · DZE Implant, Endosseous,... · Dental
Apr 2015 79d
KJ EXTERNAL IMPLANT SYSTEM
K140051 · DZE Implant, Endosseous,... · Dental
Oct 2014 294d
J2I IMPLANT SYSTEM
K140052 · DZE Implant, Endosseous,... · Dental
Oct 2014 294d
HERO I DENTAL IMPLANT SYSTEM
K121098 · DZE Implant, Endosseous,... · Dental
Jan 2013 281d
HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM
K121047 · DZE Implant, Endosseous,... · Dental
Oct 2012 181d
KERATOR
K112787 · NHA Abutment, Implant,... · Dental
Aug 2012 317d
KJ SUBMERGED SYSTEM
K103810 · DZE Implant, Endosseous,... · Dental
Sep 2011 259d
KJ MASK
K103019 · DZB Headgear, Extraoral,... · Dental
Jun 2011 240d
Filters
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