Dxm Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Dxm Co., Ltd.” (first 2004, latest 2020), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 231 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 34 |
| 2019 | 0 | — |
| 2020 | 1 | 248 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dxm Co., Ltd. took a median 141 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 217 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 4 | 4 |
| EIA | Unit, Operative Dental | 1 | 1 |
| EJI | Syringe, Cartridge | 1 | 1 |
Review panels
- Dental (6)
Most recent Dxm Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191221 | Cybird LED Curing Light | EBZ | 2020-01-10 | 248 |
| K173876 | Cybird LED Curing Light | EBZ | 2018-01-24 | 34 |
| K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | EBZ | 2012-11-27 | 231 |
| K081694 | DENJECTOR | EJI | 2008-09-12 | 87 |
| K042703 | CYBIRD LED CURING LIGHT | EBZ | 2004-10-12 | 12 |
| K040116 | HAWK INTRAORAL CAMERA AND ACCESSORIES | EIA | 2004-04-20 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Dxm Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dxm Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Dxm Co., Ltd.” (first 2004, latest 2020), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dxm Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dxm Co., Ltd. is 89 days.
Which FDA product codes appear under Dxm Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBZ (Activator, Ultraviolet, For Polymerization, 4); EIA (Unit, Operative Dental, 1); EJI (Syringe, Cartridge, 1).
Next steps
- See all 6 Dxm Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBZ, Dxm Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.