510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KJ Meditech Co., Ltd.

Gwangju, KR

KJ MEDITECH CO., LTD. appears in FDA device records in Gwangju, KR. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
13
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 13 510(k) clearances for KJ Meditech Co., Ltd. between 2006 and 2022. The busiest year on record is 2011, with 2. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for KJ Meditech Co., Ltd., by decision year
YearClearances
20061
20112
20122
20131
20142
20151
20161
20171
20181
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemDZESubstantially Equivalent
K173116KJ ZIRCONIA Implant SystemDZESubstantially Equivalent
K161923J2A SLA Dental Implant SystemDZESubstantially Equivalent
K151970KJ Mini Implant SystemDZESubstantially Equivalent
K150060J2A Dental Implant System, J2C Dental Implant SystemDZESubstantially Equivalent
K140052J2I IMPLANT SYSTEMDZESubstantially Equivalent
K140051KJ EXTERNAL IMPLANT SYSTEMDZESubstantially Equivalent
K121098HERO I DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K121047HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K112787KERATORNHASubstantially Equivalent
K103810KJ SUBMERGED SYSTEMDZESubstantially Equivalent
K103019KJ MASKDZBSubstantially Equivalent
K053629ANCHOR PLUS/NEO ANCHOR PLUSDZESubstantially Equivalent

Registered establishments

FDA registered establishments for KJ Meditech Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30089594193008959419KJ MEDITECH CO., LTD.21, Cheomdan venture-ro, Gwangju 61009 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain