FDA Registration
Active
🇰🇷 South Korea
DENTIUM CO.,LTD(ICT BRANCH)
Reg #: 3017403245
·
FEI: 3017403245
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- DENTIUM CO.,LTD(ICT BRANCH)
- Registration Number
- 3017403245
- FEI Number
- 3017403245
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- (16229) 76, Changnyong-daero 256beon-gil, Yeongtong-gu
- City
- Suwon Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K200271
Owner / Operator
- Firm Name
- Dentium Co.,Ltd(ICT branch)
- Operator Number
- 10076095
- Address
- (16229) 76, Changnyong-daero 256beon-gil, Yeongtong-gu
- City
- Suwon
- State
- Gyeonggi
- Postal Code
- 16229
- Country
- KR
- Correspondent
- Hyojeong Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2021-04-19 |
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2020-07-07 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2020-07-07 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2020-09-06 |
Proprietary Names
rainbow CT
bright CT
bright MCT
rainbow MCT
IOX2
IOX1
iCTmotor
Establishment Types
Manufacture Medical Device