Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Healex Products, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030727 | POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT | Healex Products, Inc. | 2003-06-05 | 90 | 0 |
| K961457 | SUBLIMINATOR | Healex Products, Inc. | 1996-07-18 | 93 | 0 |
| K954976 | POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATI | Healex Products, Inc. | 1996-04-25 | 181 | 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