Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cortex Dental Implants Industries , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181580 | Cortex CAD/CAM Abutments | Cortex Dental Implants Industries , Ltd. | 2019-01-29 | 228 | 0 |
| K163385 | Cortex Dental Implant System | Cortex Dental Implants Industries , Ltd. | 2017-08-29 | 270 | 0 |
| K131258 | SATURN DENTAL IMPLANT | Cortex Dental Implants Industries , Ltd. | 2014-03-17 | 319 | 0 |
| K090709 | CORTEX DENTAL IMPLANT SYSTEM | Cortex Dental Implants Industries , Ltd. | 2009-07-07 | 111 | 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