Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dxm Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
248 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191221 | Cybird LED Curing Light | Dxm Co., Ltd. | 2020-01-10 | 248 | 0 |
| K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | 2018-01-24 | 34 | 0 |
| K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | Dxm Co., Ltd. | 2012-11-27 | 231 | 0 |
| K081694 | DENJECTOR | Dxm Co., Ltd. | 2008-09-12 | 87 | 0 |
| K042703 | CYBIRD LED CURING LIGHT | Dxm Co., Ltd. | 2004-10-12 | 12 | 0 |
| K040116 | HAWK INTRAORAL CAMERA AND ACCESSORIES | Dxm Co., Ltd. | 2004-04-20 | 91 | 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