Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hygedent, Inc. — 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) |
|---|---|---|---|---|---|
| K203824 | VPS Impression Material | Hygedent, Inc. | 2021-04-19 | 111 | 0 |
| K191034 | VPS Impression Material | Hygedent, Inc. | 2019-09-04 | 139 | 0 |
| K170812 | HygePLUS Alginate Impression Material | Hygedent, Inc. | 2017-07-26 | 131 | 0 |
| K140074 | HYGEDENT ALGINATE IMPRESSION MATERIAL | Hygedent, Inc. | 2014-05-21 | 128 | 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