Beijing C-Root Dental Medical Devices Co., Ltd.
Manufacturer and brand owner in Beijing, China. 6 device types, 4 products catalogued, 2 clearances.
Beijing C-Root Dental Medical Devices Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Dam, Rubber, Needle, Dental and 4 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
6device types registered with the FDA
4products catalogued under its own name
2510(k) clearances
Registration
| Registered name | BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021971019 |
| FEI number | 3021971019 |
| DUNS | 415018580 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 北京赛濡特口腔医疗器械有限公司 |
|---|---|
| Unified social credit code | 91110108MA018DR5XM |
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | Room 301, Building 10, Yard 12, Middle Juyuan Road, Mapo Town, Shunyi District |
| Postal code | 101300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Dam, Rubber | Class 1 | C-Root Leak Seak, C-Root Leak Seal (blue), C-Root Dam | 2023 | 23 |
| File, Pulp Canal, Endodontic | Class 1 | C-Root File | 2022 | 53 |
| Needle, Dental | Class 1 | Disposable tips | 2024 | 56 |
| Preparer, Root Canal Endodontic | Class 1 | C-Root EDTA Gel, EDTA root canal lubrication gel, C-Root EDTA Solution | 2023 | 8 |
| Resin, Root Canal Filling | Class 2 | Injectable Root Canal Bioceramic Sealer, C-Root BP | 2022 | 4 |
| Syringe, Periodontic, Endodontic, Irrigating | Class 1 | C-Root Sodium Hypochlorite Solution (3%, 5%, 5.25%) | 2025 | 32 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240365 | 2024-05-10 | KIF | Traditional | This company |
| K212983 | 2021-12-08 | KIF | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Main products | Bioceramic root canal sealer, Repair putty, Ni-Ti rotary files, EDTA gel, Calcium hydroxide |
| Certifications | ISO13485, CE, FDA, NMPA |
| Export markets | 130+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.