Izenimplant Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Izenimplant Co., Ltd.” (first 2022, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 156 days. Since 2017 the median was 156 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 |
|---|---|---|
| 2022 | 1 | 366 |
| 2023 | 3 | 86 |
| 2024 | 2 | 210 |
| 2025 | 0 | — |
| 2026 | 2 | 156 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Izenimplant Co., Ltd. took a median 156 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 | 6 | 6 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
Review panels
- Dental (8)
Most recent Izenimplant Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253334 | ZENEX Implant System_Short (R-System) | DZE | 2026-03-16 | 167 |
| K252585 | ZENEX Implant System_R-System | DZE | 2026-01-08 | 146 |
| K240560 | ZENEX Implant System_Long | DZE | 2024-10-30 | 244 |
| K232170 | Ti Link Abutment | NHA | 2024-01-12 | 175 |
| K233163 | ZENEX Implant System_Short | DZE | 2023-12-19 | 83 |
| K231557 | ZENEX FreeMilling & CCM Cast Abutment | NHA | 2023-08-24 | 86 |
| K230630 | ZENEX Implant System_Narrow | DZE | 2023-07-31 | 146 |
| K211090 | ZENEX Implant System | DZE | 2022-04-13 | 366 |
Recalls
openFDA lists no recalls under a recalling firm named Izenimplant 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 Izenimplant Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Izenimplant Co., Ltd.” (first 2022, latest 2026), across 2 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 Izenimplant Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Izenimplant Co., Ltd. is 156 days. Since 2017: 156 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Izenimplant Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6); NHA (Abutment, Implant, Dental, Endosseous, 2).
Next steps
- See all 8 Izenimplant Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Izenimplant 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.