Manufacturer registered with FDA
Dentex Dental Industrial Corp
Taipei, Taiwan. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1Taiwan
Registered in 3 markets
Where regulators' registries name Dentex Dental Industrial Corp 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 | Dentex Dental Industrial Corp | 3 device types | — | Below |
| Australia | TGA | Manufacturer | Dentex Dental Industrial Corp | 5 | 2005–2007 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DENTEX DENTAL INDUSTRIAL CORP. | 1 | 2008–2008 | 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 Dentex Dental Industrial Corp 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 Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | — | 2008 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | — | 2008 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | — | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTEX DENTAL INDUSTRIAL CORP.FDA reg. 9680740 | New Taipei City, Taiwan | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027465). 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.