Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentlight, 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) |
|---|---|---|---|---|---|
| K201387 | Ultrafast, Ultrafast Plus, Ultrafast Lite | Dentlight, Inc. | 2021-02-26 | 275 | 0 |
| K180065 | FUSION Plus Curing Light | Dentlight, Inc. | 2019-04-19 | 465 | 0 |
| K101140 | DENTLIGHT ORAL EXAM LIGHT KIT | Dentlight, Inc. | 2010-07-15 | 84 | 0 |
| K052593 | FUSION CURING LIGHT | Dentlight, Inc. | 2005-09-28 | 7 | 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