Manufacturer registered with FDA
Codent Technical Industry Co., Ltd.
Kaohsiung, Taiwan. Lists 3 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 52004–2024
- Markets registered in
- 68 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name Codent Technical Industry Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Codent Technical Industry Co., Ltd. | 5 clearances | 2004–2024 | Below |
| Canada | Health Canada | Registration holder | CODENT TECHNICAL INDUSTRY CO., LTD | 4 | 2014–2014 | Pure Global AI |
| Australia | TGA | Manufacturer | Codent Technical Industry Co Ltd | 1 | 2025–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | CODENT TECHNICAL INDUSTRY CO.,LTD | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Codent Technical Industry Co., Ltd. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | CODENT TECHNICAL INDUSTRY CO., LTD | 1 | 2020–2020 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Codent Technical Industry Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPSCODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIESHigh Speed Handpieces And Accessories | 2021 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | 2021 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Fiber Optic Brushless Electronic Micromotor (iM100) | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Codent Technical Industry Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Mar 2024 | K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | EBW Handpiece and Cord Foot Controller |
| 8 Dec 2015 | K152146 | High Speed Handpieces and Accessories | EFB Dental Air-Powered Handpiece |
| 24 Apr 2015 | K150798 | Codent Low Speed Dental Handpieces and Accessories | EFB Dental Air-Powered Handpiece |
| 24 Oct 2014 | K133069 | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | EFB Dental Air-Powered Handpiece |
| 6 Feb 2004 | K033213 | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS | EFB Dental Air-Powered Handpiece |
Some of these clearances are listed with FDA today by another company: Beyes Dental Inc (2), Young Innovations Inc (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CODENT TECHNICAL INDUSTRY CO.,LTD.FDA reg. 3004082152 | Kaohsiung, Taiwan | Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083535). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.