Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hdx Will Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
189 daysmedian FDA review time
255 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211159 | eco-x Series (eco-x, eco-x-s) | Hdx Will Corp. | 2021-12-30 | 255 | 0 |
| K211114 | Will3D | Hdx Will Corp. | 2021-12-15 | 245 | 0 |
| K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | Hdx Will Corp. | 2021-10-19 | 92 | 0 |
| K192700 | Xcam | Hdx Will Corp. | 2019-12-27 | 92 | 0 |
| K190357 | Star-X, Intraoral X-ray System | Hdx Will Corp. | 2019-03-15 | 28 | 0 |
| K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Hdx Will Corp. | 2018-11-21 | 189 | 0 |
| K172168 | WillCeph | Hdx Will Corp. | 2018-03-21 | 246 | 0 |
| K170180 | Will3D | Hdx Will Corp. | 2017-05-08 | 109 | 0 |
| K160140 | DENTRIa series | Hdx Will Corp. | 2016-09-30 | 253 | 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