FDA Registration
Active
🇨🇳 China
BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD.
Reg #: 3021971019
·
FEI: 3021971019
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD.
- Registration Number
- 3021971019
- FEI Number
- 3021971019
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 301, Building 10, Yard 12, Middle Juyuan Road, Mapo Town, Shunyi District
- City
- Beijing
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240365
Owner / Operator
- Firm Name
- Beijing C-Root Dental Medical Devices Co., LTD.
- Operator Number
- 10084370
- Address
- Room 301, Building 10, Yard 12, Middle Juyuan Road, Mapo Town, Shunyi District
- City
- Beijing
- State
- CN-BJ
- Postal Code
- 101300
- Country
- CN
- Correspondent
- Li Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Dental | DZM | Class 1 | Dental | No | 2024-05-20 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2023-10-30 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2024-05-16 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2022-02-15 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2025-11-26 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2023-10-27 |
Proprietary Names
Disposable tips
C-Root EDTA Gel
C-Root EDTA Solution
EDTA root canal lubrication gel
C-Root BP
Injectable Root Canal Bioceramic Sealer
C-Root File
C-Root Sodium Hypochlorite Solution (3%, 5%, 5.25%)
C-Root Leak Seal (blue)
C-Root Leak Seak
C-Root Dam
Establishment Types
Manufacture Medical Device