Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OYH · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
254 daysmedian FDA review time
366 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183018 | VPro5 | Propel Orthodontics, LLC | 2019-11-01 | 366 | 0 |
| K170093 | AcceleDent Optima | Orthoaccel Technology, Inc. | 2017-05-26 | 135 | 0 |
| K153048 | AcceleDent Aura | Orthoaccel Technologies, Inc. | 2016-07-08 | 263 | 0 |
| K130643 | ACCELEDENT AURA | Orthoaccel Technologies, Inc. | 2013-04-23 | 43 | 0 |
| K110661 | ACCELEDENT | Orthoaccel Technologies, Inc. | 2011-11-17 | 254 | 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