Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tomy, 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) |
|---|---|---|---|---|---|
| K180718 | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | Tomy, Inc. | 2018-10-30 | 225 | 0 |
| K160615 | ORTHODONTIC CERAMIC BRACKETS 1.1 | Tomy, Inc. | 2016-08-26 | 176 | 0 |
| K123092 | CERAMIN BRACKETS Z | Tomy, Inc. | 2012-12-21 | 80 | 0 |
| K123094 | ORTHODONTIC CERAMIC BRACKETS | Tomy, Inc. | 2012-12-13 | 72 | 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