Manufacturer registered with FDA
Ray Co., Ltd,
Yongin-si, South Korea. Lists 9 dental device types with FDA across 1 registered establishment, and holds 21 510(k) clearances as applicant.
- Device types listed
- 9
- Brands and models
- 41
- 510(k) clearances
- 212013–2026
- Markets registered in
- 419 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Ray 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 | Ray Co., Ltd, | 21 clearances | 2013–2026 | Below |
| Taiwan | TFDA | Manufacturer | RAY CO., LTD.Ray Co., Ltd. | 15 | 2010–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | RAY Co., LtdRay Co., Ltd | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | RAY Co., Ltd. | 2 | 2024–2025 | 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 Ray 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 |
|---|---|---|---|---|
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | R2 Studio QRAYPreMiereRAYQuantumRAYSCAN ?-Expert3DRAYSCAN ?+RAYSCAN A+RAYSCAN SRAYSCAN StudioRCT600RCT700 6 moreRCT800RCT820RCT820-SCVision 16Vision 18Vision 20 | 2018 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | RAYSCAN ?-OCLRAYSCAN ?-OCSRAYSCAN ?-PRAYSCAN ?-SCRayscan A-ExpertRIOScanRPS500 | 2015 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | RAYDent DesignerRAYDENT SWRAYiOSRAYiOS2 | 2022 |
| Intraoral X-Ray UnitEAP · Class 2 | Dental X-ray units | Lister | RIOSensor+ | 2023 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | RAYDENT DM | 2017 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | RIT-BTRIT-LLRIT-LURIT-MLRIT-MURIT-PARIT-PBRIT-SLRIT-SU | 2018 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | RAYDENT C&B | 2017 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | RAYDENT SG | 2017 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | RAYDENT SW | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Ray Co., Ltd, as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Apr 2026 | K260462 | RCT800 | OAS Dental Computed Tomography X-Ray |
| 25 Nov 2025 | K251798 | RCT700 | OAS Dental Computed Tomography X-Ray |
| 12 Mar 2025 | K243903 | RCT600 | OAS Dental Computed Tomography X-Ray |
| 16 May 2024 | K233625 | RAYDENT SW | PNN Orthodontic Software |
| 18 Apr 2024 | K232325 | RAYSCAN a-Expert | MUH Digital Extraoral Source X-Ray System |
| 31 Aug 2023 | K232287 | RAYSCAN a-Expert3D | OAS Dental Computed Tomography X-Ray |
| 11 Apr 2023 | K230753 | RCT800 | OAS Dental Computed Tomography X-Ray |
| 29 Nov 2021 | K213226 | RCT700 | OAS Dental Computed Tomography X-Ray |
| 22 Oct 2019 | K192737 | RCT800 | OAS Dental Computed Tomography X-Ray |
| 24 Apr 2019 | K190812 | RAYSCAN a-Expert3D | OAS Dental Computed Tomography X-Ray |
| 14 Dec 2018 | K182805 | RCT800 | OAS Dental Computed Tomography X-Ray |
| 16 Oct 2018 | K182614 | RCT700 | OAS Dental Computed Tomography X-Ray |
| 27 Jul 2018 | K181452 | RCT800 | OAS Dental Computed Tomography X-Ray |
| 20 Jun 2016 | K160525 | RCT700 | OAS Dental Computed Tomography X-Ray |
| 15 Apr 2016 | K160788 | RIOScan (RPS500) | MUH Digital Extraoral Source X-Ray System |
| 22 Apr 2015 | K142058 | RAYSCAN A-EXPERT | MUH Digital Extraoral Source X-Ray System |
| 17 Apr 2015 | K142247 | RAYSCAN A-EXPERT 3D | OAS Dental Computed Tomography X-Ray |
| 1 Nov 2013 | K131695 | RAYSCAN A-EXPERT 3D | OAS Dental Computed Tomography X-Ray |
| 1 Nov 2013 | K131693 | RAYSCAN A-EXPERT | MUH Digital Extraoral Source X-Ray System |
| 15 Mar 2013 | K122918 | RAYSCAN A-EXPERT | MUH Digital Extraoral Source X-Ray System |
| 12 Mar 2013 | K122981 | RAYSCAN A-EXPERT 3D | OAS Dental Computed Tomography X-Ray |
Also lists devices cleared under other names
Ray Co., Ltd, lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Trophy Radiologie (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Apr 1995 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | EAP Intraoral X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RAY CO., LTD,FDA reg. 3010445368 | Yongin-si Gyeonggi, South Korea | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045096). 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.