Data / Medical devices / China / Riton 3D Technology Co., Ltd
Riton 3D Technology Co., Ltd: FDA-registered device maker in Guangzhou Guangdong, China, 1 510(k) clearance
Riton 3D Technology Co., Ltd is registered with the FDA (registration 3027303702) in Guangzhou Guangdong, China. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027303702
- Address
- Room 201, 2/F, No. 349 Longxi Middle Road, Liwan District, Guangzhou Guangdong, China, 510375
- Owner or operator
- Riton 3D Technology Co., Ltd (10087560)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 31, 2023
- Registered through
- 2026
- Brand names listed
- Casting Wax Resin Model C1-G, CoCr Alloy Powder RXT-01, CoCrMo Alloy Powder C02, CoCrMoW Alloy Powder C01, Cobalt-Chromium Dental Alloy Powder,CoCrW,CoCrMo,CoCrMoW, Dental Model Model H1-G, Dental Model Model H1-Y, Dental Model Model S1-G and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Manufacturer | accessdata.fda.gov |
| Material, External Aesthetic Restoration, No Adhesive | NOK | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Base, Shellac | EEA | 1 | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2024 | K243103 | Denture Base | EBI | Substantially Equivalent | Riton 3D Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Positioner, Tooth, Preformed
- All makers of Wax, Dental, Intraoral
- All makers of Alloy, Metal, Base
- All makers of Additively Manufactured, Preformed, Resin Denture Tooth
- All makers of Resin, Denture, Relining, Repairing, Rebasing
Updated December 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.