Manufacturer registered with FDA
Bandex Industrial Corp.
Zhuhai City, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 413 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Bandex 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 | Bandex Industrial Corp. | 3 device types | — | Below |
| Brazil | ANVISA | Manufacturer | BANDEX INDUSTRIAL CORPORATION | 11 | 2016–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Bandex Industrial Corp. | 1 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | BANDEX INDUSTRIAL CORPORATION | 1 | — | 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 Bandex 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 |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | TOOTHBRUSH, MANUAL | 2024 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | pick, massaging | 2024 |
| Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1 | — | Maker | UNIT, ULTRAVIOLET SANITATION/STERILIZATION (FOR TOOTHBRUSHES), NON-STERILE | 2024 |
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 |
|---|---|---|
| BANDEX INDUSTRIAL CORP.FDA reg. 3007327603 | Zhuhai City Guangdong, China | Contract manufacturer, Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027300). 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.