Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Deldent , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
55 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K014249 | JETPOLISHER | Deldent , Ltd. | 2002-02-19 | 55 | 0 |
| K014252 | JETSTREAM | Deldent , Ltd. | 2002-02-19 | 55 | 0 |
| K014245 | JETSONIC 2000 | Deldent , Ltd. | 2002-01-29 | 34 | 0 |
| K014238 | DELSONIC 2000 | Deldent , Ltd. | 2002-01-24 | 29 | 0 |
| K013969 | MINIBLASTER | Deldent , Ltd. | 2002-01-10 | 38 | 0 |
| K011179 | DELDENT ULTRASONIC INSERTS | Deldent , Ltd. | 2001-06-05 | 49 | 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