Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kj Meditech Co., Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
294 daysmedian FDA review time
484 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202046 | LOTA SLA Dental Implant System and LOTA HA Dental Implant Sy | Kj Meditech Co., Ltd. | 2022-03-01 | 586 | 0 |
| K173116 | KJ ZIRCONIA Implant System | Kj Meditech Co., Ltd. | 2018-06-28 | 272 | 0 |
| K161923 | J2A SLA Dental Implant System | Kj Meditech Co., Ltd. | 2017-11-09 | 484 | 0 |
| K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | 2016-10-21 | 463 | 0 |
| K150060 | J2A Dental Implant System, J2C Dental Implant System | Kj Meditech Co., Ltd. | 2015-04-02 | 79 | 0 |
| K140052 | J2I IMPLANT SYSTEM | Kj Meditech Co., Ltd. | 2014-10-30 | 294 | 0 |
| K140051 | KJ EXTERNAL IMPLANT SYSTEM | Kj Meditech Co., Ltd. | 2014-10-30 | 294 | 0 |
| K121098 | HERO I DENTAL IMPLANT SYSTEM | Kj Meditech Co., Ltd. | 2013-01-17 | 281 | 0 |
| K121047 | HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM | Kj Meditech Co., Ltd. | 2012-10-04 | 181 | 0 |
| K112787 | KERATOR | Kj Meditech Co., Ltd. | 2012-08-08 | 317 | 0 |
| K103810 | KJ SUBMERGED SYSTEM | Kj Meditech Co., Ltd. | 2011-09-14 | 259 | 0 |
| K103019 | KJ MASK | Kj Meditech Co., Ltd. | 2011-06-09 | 240 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda