Registered with FDA
Ray America Inc.
Fort Lee, NJ, United States. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 34
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Ray America Inc. 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 | Lister | RAYPreMiereRAYQUANTUMRAYSCAN ?-Expert 3DRAYSCAN a+RAYSCAN A+ Vision 16RAYSCAN ALPHA PLUSRAYSCAN SRAYSCAN S Vision 20RAYSCAN STUDIORCT600 Computed Tomography X-ray System 5 moreRCT700RCT800VISION 16VISION 18VISION 20 | 2015 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | Cocoon Portable Handheld X-Ray SystemRAYSCAN ?-ExpertRIOSCAN | 2015 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | RAYDENT SWRAYiOSRAYiOS2 | 2022 |
| Intraoral X-Ray UnitEAP · Class 2 | Dental X-ray units | Lister | RIOSensor+ Intraoral X-ray unit | 2023 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | RAYDENT DM | 2017 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | RIT-LLRIT-LURIT-MLRIT-MURIT-PARIT-PBRIT-SLRIT-SU | 2019 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Lister | RAYDENT C&B | 2017 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | RAYDENT SG | 2017 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Lister | 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
Also lists devices cleared under other names
Ray America Inc. 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: Ray Co., Ltd, (11), Dexcowin Co., Ltd. (1), Trophy Radiologie (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 25 Nov 2025 | K251798 | RCT700 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 12 Mar 2025 | K243903 | RCT600 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 16 May 2024 | K233625 | RAYDENT SW | Ray Co., Ltd, | PNN Orthodontic Software |
| 11 Apr 2023 | K230753 | RCT800 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 29 Nov 2021 | K213226 | RCT700 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 22 Oct 2019 | K192737 | RCT800 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 14 Dec 2018 | K182805 | RCT800 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 16 Oct 2018 | K182614 | RCT700 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 26 Oct 2017 | K173046 | Cocoon Portable Handheld X-Ray System | Dexcowin Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
| 15 Apr 2016 | K160788 | RIOScan (RPS500) | Ray Co., Ltd, | MUH Digital Extraoral Source X-Ray System |
| 22 Apr 2015 | K142058 | RAYSCAN A-EXPERT | Ray Co., Ltd, | MUH Digital Extraoral Source X-Ray System |
| 17 Apr 2015 | K142247 | RAYSCAN A-EXPERT 3D | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 19 Apr 1995 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | EAP Intraoral X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RAY AMERICA INCFDA reg. 3011471624 | Fort Lee, NJ, United States | Complaint file establishment |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048938). 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.