Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
YAMAHACHI DENTAL MFG., Co. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254091 | GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. | 2026-04-06 | 108 | 0 |
| K233859 | BASIS FLOW II | YAMAHACHI DENTAL MFG., Co. | 2024-03-05 | 90 | 0 |
| K172683 | Yamahachi Pink CAD/CAM Disk | YAMAHACHI DENTAL MFG., Co. | 2018-01-16 | 132 | 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