Kj Meditech Co., Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Kj Meditech Co., Ltd.” (first 2006, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 281 days. Since 2017 the median was 484 days, against 191 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 249 |
| 2013 | 1 | 281 |
| 2014 | 2 | 294 |
| 2015 | 1 | 79 |
| 2016 | 1 | 463 |
| 2017 | 1 | 484 |
| 2018 | 1 | 272 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 586 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Kj Meditech Co., Ltd. took a median 484 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 11 | 11 |
| DZB | Headgear, Extraoral, Orthodontic | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (13)
Most recent Kj Meditech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202046 | LOTA SLA Dental Implant System and LOTA HA Dental Implant System | DZE | 2022-03-01 | 586 |
| K173116 | KJ ZIRCONIA Implant System | DZE | 2018-06-28 | 272 |
| K161923 | J2A SLA Dental Implant System | DZE | 2017-11-09 | 484 |
| K151970 | KJ Mini Implant System | DZE | 2016-10-21 | 463 |
| K150060 | J2A Dental Implant System, J2C Dental Implant System | DZE | 2015-04-02 | 79 |
| K140052 | J2I IMPLANT SYSTEM | DZE | 2014-10-30 | 294 |
| K140051 | KJ EXTERNAL IMPLANT SYSTEM | DZE | 2014-10-30 | 294 |
| K121098 | HERO I DENTAL IMPLANT SYSTEM | DZE | 2013-01-17 | 281 |
| K121047 | HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM | DZE | 2012-10-04 | 181 |
| K112787 | KERATOR | NHA | 2012-08-08 | 317 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kj Meditech Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Kj Meditech Co., Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Kj Meditech Co., Ltd.” (first 2006, latest 2022), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kj Meditech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kj Meditech Co., Ltd. is 281 days. Since 2017: 484 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Kj Meditech Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 11); DZB (Headgear, Extraoral, Orthodontic, 1); NHA (Abutment, Implant, Dental, Endosseous, 1).
Next steps
- See all 13 Kj Meditech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Kj Meditech Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.