Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Dabi-Atlante America Corp. · 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) |
|---|---|---|---|---|---|
| K926154 | HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR | Dabi-Atlante America Corp. | 1994-03-04 | 452 | 0 |
| K926155 | CA AND ST | Dabi-Atlante America Corp. | 1994-03-04 | 452 | 0 |
| K922437 | HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270 | Dabi-Atlante America Corp. | 1992-12-21 | 213 | 0 |
| K912997 | MINIFLEX AND PERSONAL UNIT | Dabi-Atlante America Corp. | 1991-10-30 | 114 | 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