Data / Medical devices / China / Beijing C-Root Dental Medical Devices Co., Ltd.
Beijing C-Root Dental Medical Devices Co., Ltd.: FDA-registered device maker in Beijing, China, 2 510(k) clearances
Beijing C-Root Dental Medical Devices Co., Ltd. is registered with the FDA (registration 3021971019) in Beijing, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 10, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021971019
- Address
- Room 301, Building 10, Yard 12, Middle Juyuan Road, Mapo Town, Shunyi District, Beijing, China, 101300
- Owner or operator
- Beijing C-Root Dental Medical Devices Co., LTD. (10084370)
- Roles
- Manufacturer
- First device listed
- February 15, 2022
- Registered through
- 2027
- Brand names listed
- C-Root BP, C-Root Dam, C-Root EDTA Gel, C-Root EDTA Solution, C-Root File, C-Root Leak Seak, C-Root Leak Seal (blue), C-Root Sodium Hypochlorite Solution (3%, 5%, 5.25%) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dam, Rubber | EIE | 1 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Dental | DZM | 1 | Manufacturer | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 10, 2024 | K240365 | Bioceramic Root Repair Material (C-Root BP) | KIF | Substantially Equivalent | Beijing C-Root Dental Medical Devices Co., Ltd. | accessdata.fda.gov |
| December 8, 2021 | K212983 | Injectable Root Canal Bioceramic Sealer | KIF | Substantially Equivalent | Beijing C-Root Dental Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of File, Pulp Canal, Endodontic
- All makers of Syringe, Periodontic, Endodontic, Irrigating
- All makers of Resin, Root Canal Filling
- All makers of Preparer, Root Canal Endodontic
- All makers of Needle, Dental
- All makers of Dam, Rubber
Updated May 10, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.