FDA Registration
Active
🇰🇷 South Korea
RAY CO., LTD,
Reg #: 3010445368
·
FEI: 3010445368
·
Expires 2026
Products
10
Proprietary Names
43
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- RAY CO., LTD,
- Registration Number
- 3010445368
- FEI Number
- 3010445368
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1F~3F, 4F(Part), 5F, 265, Daeji-ro
- City
- Yongin-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K142058
Owner / Operator
- Firm Name
- Ray Co., Ltd,
- Operator Number
- 10045096
- Address
- 1F~3F, 4F(Part), 5F, 265, Daeji-ro, Suji-gu
- City
- Yongin-si
- State
- Gyeonggi
- Postal Code
- 16882
- Country
- KR
US Agent
- Business Name
- RAY AMERICA INC
- Contact Name
- JANGTAE (BRANDON) YOO
- Address
- 400 Kelby Street, Ste 1500
- City
- Fort Lee
- State
- NJ
- ZIP
- 07024
- Country
- US
- [email protected]
- Phone
- 201 7450200
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2018-12-20 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2017-05-18 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2015-04-24 |
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2026-04-12 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-05-25 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2022-05-23 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2017-05-18 |
| Unit, X-Ray, Intraoral | EAP | Class 2 | Dental | No | 2023-11-22 |
| Orthodontic Software | PNN | Class 2 | Dental | No | 2024-05-20 |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | Class 1 | Dental | No | 2017-05-18 |
Proprietary Names
RIT-LL
RIT-SL
RIT-LU
RIT-ML
RIT-PB
RIT-SU
RIT-MU
RIT-PA
RIT-BT
RAYDENT DM
Rayscan A-Expert
Vision 20
RAYSCAN S
RAYSCAN STUDIO
Vision 18
RAYPreMiere
RCT800
RCT820-SC
RCT820
R2 Studio Q
RAYSCAN ?-SC
RAYSCAN ?-OCL
RAYSCAN ?-P
RAYSCAN ?-OCS
RAYSCAN ?+
Vision 16
RCT700
SMARTDent
RAYiOS
RAYiOS2
RAYDent Designer
RPS500
RIOScan
RAYSCAN Studio
RCT600
RAYQuantum
RAYDENT SG
RAYSCAN ?-Expert3D
RIOSensor+
RAYSCAN A+
RAYDENT SW
OnDemand3DTM
RAYDENT C&B
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device