Manufacturer registered with FDA
Beijing C-Root Dental Medical Devices Co., LTD.
Beijing, China. Lists 6 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 11
- 510(k) clearances
- 22021–2024
- Markets registered in
- 59 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Beijing C-Root Dental Medical Devices Co., LTD. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Beijing C-Root Dental Medical Devices Co., LTD. | 2 clearances | 2021–2024 | Below |
| European Union | EUDAMED | Manufacturer | Beijing C-Root Dental Medical Devices Co., LTD. | 5 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTDBEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD | 1 | 2024–2024 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Beijing C-Root Dental Medical Devices Co., LTD. | 1 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Beijing C-Root Dental Medical Devices Co., LTD. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | C-Root BPInjectable Root Canal Bioceramic Sealer | 2022 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Disposable tips | 2024 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | C-Root Sodium Hypochlorite Solution (3%, 5%, 5.25%) | 2025 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | C-Root DamC-Root Leak SeakC-Root Leak Seal (blue) | 2023 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | C-Root EDTA GelC-Root EDTA SolutionEDTA root canal lubrication gel | 2023 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | C-Root File | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Beijing C-Root Dental Medical Devices Co., LTD. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BEIJING C-ROOT DENTAL MEDICAL DEVICES CO., LTD.FDA reg. 3021971019 | Beijing, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084370). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.