Data / Medical devices / Taiwan / Codent Technical Industry Co.,ltd.
Codent Technical Industry Co.,ltd.: FDA-registered device maker in Kaohsiung, Taiwan, 5 510(k) clearances
Codent Technical Industry Co.,ltd. is registered with the FDA (registration 3004082152) in Kaohsiung, Taiwan. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 11, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004082152
- Address
- 2F., No.100, Luke 5th Rd., Luzhu Dist., Kaohsiung, Taiwan, 821
- Owner or operator
- CODENT TECHNICAL INDUSTRY CO.,LTD. (10083535)
- Roles
- Foreign private label distributor, Manufacturer
- First device listed
- November 29, 2021
- Registered through
- 2026
- Brand names listed
- CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS, CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES, Codent Low Speed Dental Handpieces And Accessories, Fiber Optic Brushless Electronic Micromotor (iM100), High Speed Handpieces And Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Controller, Foot, Handpiece And Cord | EBW | 1 | Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 11, 2024 | K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | EBW | Substantially Equivalent | Codent Technical Industry Co., Ltd. | accessdata.fda.gov |
| December 8, 2015 | K152146 | High Speed Handpieces and Accessories | EFB | Substantially Equivalent | Codent Technical Industry Co., Ltd. | accessdata.fda.gov |
| April 24, 2015 | K150798 | Codent Low Speed Dental Handpieces and Accessories | EFB | Substantially Equivalent | Codent Technical Industry Co., Ltd. | accessdata.fda.gov |
| October 24, 2014 | K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | EFB | Substantially Equivalent | Codent Technical Industry Co., Ltd. | accessdata.fda.gov |
| February 6, 2004 | K033213 | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS | EFB | Substantially Equivalent | Codent Technical Industry Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Controller, Foot, Handpiece And Cord
- All makers of Handpiece, Air-Powered, Dental
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
Updated March 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.