Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DZH · 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) |
|---|---|---|---|---|---|
| K031793 | DENTATUS OSCIOMAT | Dentatus USA , Ltd. | 2003-11-13 | 156 | 0 |
| K935443 | ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS | Osada Electric Co., Ltd. | 1994-09-20 | 312 | 0 |
| K760958 | SURGICAL OSCILLATING SAW | American Safety Equipment Corp. | 1976-11-16 | 15 | 0 |
| K760957 | SURGICAL RECIPROCATING SAW | American Safety Equipment Corp. | 1976-11-15 | 14 | 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