Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Izenimplant Co., Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
366 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026-03-16 | 167 | 0 |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026-01-08 | 146 | 0 |
| K240560 | ZENEX Implant System_Long | Izenimplant Co., Ltd. | 2024-10-30 | 244 | 0 |
| K232170 | Ti Link Abutment | Izenimplant Co., Ltd. | 2024-01-12 | 175 | 0 |
| K233163 | ZENEX Implant System_Short | Izenimplant Co., Ltd. | 2023-12-19 | 83 | 0 |
| K231557 | ZENEX FreeMilling & CCM Cast Abutment | Izenimplant Co., Ltd. | 2023-08-24 | 86 | 0 |
| K230630 | ZENEX Implant System_Narrow | Izenimplant Co., Ltd. | 2023-07-31 | 146 | 0 |
| K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022-04-13 | 366 | 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