Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DYJ — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
227 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970930 | BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCE | Cleft Palate Appliances, Inc. | 1997-04-23 | 41 | 0 |
| K935154 | DENTAURUM EXPANSION SCREWS | Dentauraum, Inc. | 1994-02-03 | 98 | 0 |
| K925088 | EXPANSION SCREWS | Forestadent | 1993-05-22 | 227 | 0 |
| K912417 | MOLAR DISTALIZING ASSEMBLY | American Orthodontics | 1991-12-20 | 203 | 0 |
| K843705 | MANDIBULATOR JAW POSITIONER | A Company, Inc. | 1984-11-14 | 54 | 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