Codent Technical Industry Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Codent Technical Industry Co., Ltd.” (first 2004, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 127 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 389 |
| 2015 | 2 | 78 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 259 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Codent Technical Industry Co., Ltd. took a median 259 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 262 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 4 | 4 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
Review panels
- Dental (5)
Most recent Codent Technical Industry Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | EBW | 2024-03-11 | 259 |
| K152146 | High Speed Handpieces and Accessories | EFB | 2015-12-08 | 127 |
| K150798 | Codent Low Speed Dental Handpieces and Accessories | EFB | 2015-04-24 | 29 |
| K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | EFB | 2014-10-24 | 389 |
| K033213 | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS | EFB | 2004-02-06 | 126 |
Recalls
openFDA lists no recalls under a recalling firm named Codent Technical Industry 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 Codent Technical Industry Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Codent Technical Industry Co., Ltd.” (first 2004, latest 2024), across 2 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 Codent Technical Industry Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Codent Technical Industry Co., Ltd. is 127 days.
Which FDA product codes appear under Codent Technical Industry Co., Ltd.?
The most frequent FDA product codes under this applicant name are EFB (Handpiece, Air-Powered, Dental, 4); EBW (Controller, Foot, Handpiece And Cord, 1).
Next steps
- See all 5 Codent Technical Industry Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EFB, Codent Technical Industry 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.