Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DYT — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935856 | DENTAURUM SPACE MAINTAINER | Dentauraum, Inc. | 1994-04-28 | 141 | 0 |
| K864376 | FIBERBOND | Dentec, Inc. | 1987-04-07 | 153 | 0 |
| K812239 | UNITEK PALATAL BAR | Unitek Corp. | 1981-09-21 | 41 | 0 |
| K780814 | SAFETY STOP NECKSTRAP | Northwest Orthodontics, Inc. | 1978-06-30 | 43 | 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