Manufacturer registered with FDA
Guangzhou Riton Biomaterial Co., LTD
Guangzhou, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Guangzhou Riton Biomaterial 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 | Guangzhou Riton Biomaterial Co., LTD | 1 device types | — | Below |
| Brazil | ANVISA | Manufacturer | Guangzhou Riton Biomaterial Co., Ltd. | 1 | 2016–2016 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Guangzhou Riton Biomaterial Co., Ltd. | 1 | 2019–2019 | 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 Guangzhou Riton Biomaterial 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 |
|---|---|---|---|---|
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Customised Orthodontic Bracket SetCustomized Lingual Orthodontic BracketeLock Buccal BracketeLock Lingual 2D BracketeLock Lingual 3D BracketStepwise Lingual Appliance | 2013 |
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 |
|---|---|---|
| GUANGZHOU RITON BIOMATERIAL CO., LTDFDA reg. 3009233378 | Guangzhou Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043584). 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.