Manufacturer registered with FDA
Riton 3D Technology Co., Ltd
Guangzhou, China. Lists 8 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 8
- Brands and models
- 29
- 510(k) clearances
- 12024–2024
- Markets registered in
- 211 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Riton 3D Technology 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 | Riton 3D Technology Co., Ltd | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | Riton 3D Technology Co., Ltd | 11 | — | 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 Riton 3D Technology 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 |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Dental Model Model H1-GDental Model Model H1-YDental Model Model S1-GDental Model Model S1-YDental Model Model V1-GDental Model Model V1-YDental Model Model W1-BFlexible Denture Base Model F1-TPIBT Model BT1-TTemporary Model Model T1-A1 3 moreTemporary Model Model T1-A2Temporary Model Model T1-A3Tray Model TR1-B | 2023 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Denture Base Model D1-DPDenture Base Model F1-TP | 2024 |
| Shellac Base PlateEEA · Class 1 | — | Maker | Try-in Model TN1-A2 | 2025 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Casting Wax Resin Model C1-G | 2024 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Maker | Cobalt-Chromium Dental Alloy Powder,CoCrW,CoCrMo,CoCrMoWCoCr Alloy Powder RXT-01CoCrMo Alloy Powder C02CoCrMoW Alloy Powder C01Nicr Alloy Powder N03Titanium Alloy Powder TC4 | 2023 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Splint Model HS1-TSplint Model SS1-T | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Surgical Guide Model SG1-T | 2023 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | Denture Teeth Model DT1-A1Denture Teeth Model DT1-A2Denture Teeth Model DT1-A3 | 2023 |
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 |
|---|---|---|
| Riton 3D Technology Co., LtdFDA reg. 3027303702 | Guangzhou Guangdong, China | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087560). 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.