Foshan Coxo Medical Instrument Co., Ltd.
Manufacturer and brand owner in Foshan, Guangdong, China. 19 device types, 9 products catalogued, 7 clearances.
Foshan Coxo Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cutter, Surgical, Locator, Root Apex and 17 other device types. 8 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
19device types registered with the FDA
9products catalogued under its own name
7510(k) clearances
Registration
| Registered name | FOSHAN COXO MEDICAL INSTRUMENT CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014953747 |
| FEI number | 3014953747 |
| DUNS | 529860171 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 佛山市宇森医疗器械有限公司 |
|---|---|
| Unified social credit code | 91440605794620139L |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Foshan |
|---|---|
| Province | Guangdong |
| Address | No. 17, Guangming Ave., New Light Source Industrial Base, Nanhai National High-tech Zone |
| Postal code | 528226 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | Class 1 | Dental Implant Torque Wrench; C-TW1,C-TW2 | 2024 | 70 |
| Activator, Ultraviolet, For Polymerization | Class 2 | LED Curing Light; DB686 NANO, DB686 SWIFT, LED Curing Lights; DB686 HALO | 2022 | 7 |
| Amalgamator, Dental, Ac-Powered | Class 1 | Amalgamator; DB338 | 2020 | 4 |
| Controller, Foot, Handpiece And Cord | Class 1 | Dental Electrical Motors; C-PUMA MASTER, Dental Implantation Systems; C-Sailor Pro | 2022 | 4 |
| Cutter, Surgical | Class 1 | Gutta Cuts; C-BLADE | 2020 | 17 |
| Detector, Ultraviolet | Class 2 | LED Curing Lights; DB686 HALO | 2025 | 1 |
| File, Pulp Canal, Endodontic | Class 1 | F2VK-21,F2VK-25,F2VK-31, 1704-21,1704-25,1704-31, 3006VK-21,3006VK-25,3006VK-31, 4004K-21,4004K-25,4004K-31, 3506V-21,3506V-25,3506V-31, 1505-21,1505-25,1505-31 and 54 more | 2026 | 53 |
| Handpiece, Air-Powered, Dental | Class 1 | High-Speed Air Turbine Handpieces; CX207, CX207-2, CX207-A, CX207-A-2, CX207-B, CX207-B-2, Air Motors; CX235-3B, CX235-3C, CX235-3F, Straight Handpieces; CX235-2, CX235-2A, CX235-2B, CX235-2F, CX235-2G, CX235-2C, CX235-2S2, Geared Angle Handpieces; CX235C4, CX235C5, CX235C6, CX235C7, CX235C8, CX235-2S, CX235-2S1, Geared Angle Handpieces; CX235-1B, CX235-1C, CX235-1F, CX235-1G, CX235C1, CX235C2, CX235C3, High-Speed Air Turbine Handpieces; CX207-C, CX207-C-2, CX207-G, CX207-W, CX207-W-2 | 2023 | 10 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | Class 1 | Dental Electrical Motors; C-PUMA MASTER, Dental Implantation Systems; C-Sailor Pro, High-Speed Air Turbine Handpieces; CX207, CX207-2, CX207-A, CX207-A-2, CX207-B, CX207-B-2, Air Motors; CX235-3B, CX235-3C, CX235-3F, Straight Handpieces; CX235-2, CX235-2A, CX235-2B, CX235-2F, CX235-2G, CX235-2C, CX235-2S2, Geared Angle Handpieces; CX235C4, CX235C5, CX235C6, CX235C7, CX235C8, CX235-2S, CX235-2S1 and 2 more | 2022 | 9 |
| Handpiece, Direct Drive, Ac-Powered | Class 1 | Endo Motor; C-Smart-I Pro, C-SMART-I PILOT, C-Smart-mini, C-SMART-MINI AP | 2023 | 10 |
| Handpiece, Rotary Bone Cutting | Class 2 | Dental Electrical Motors; C-PUMA MASTER, Dental Implantation Systems; C-Sailor Pro | 2022 | 1 |
| Heat Source For Bleaching Teeth | Class 1 | Teeth Whitening Accelerator; C-Bright, C-Bright Ia | 2026 | 56 |
| Instrument, Filling, Plastic, Dental | Class 1 | Endodontic Obturation Systems; C-FILL; C-FILL MINI | 2021 | 23 |
| Light, Operating, Dental | Class 1 | Dental Operating Lights; CX249-21; CX249-22; CX249-23; CX249-24 | 2020 | 16 |
| Locator, Root Apex | Class U | Endo Motor; C-Smart-I Pro, C-SMART-I PILOT, C-Smart-mini, C-SMART-MINI AP, Root Apex Locator; C-ROOT I | 2022 | 8 |
| Microscope, Surgical | Class 1 | Operating Microscope; C-CLEAR-1, C-CLEAR-1(A), C-CLEAR-2, C-CLEAR-2(A) | 2020 | 9 |
| Scaler, Ultrasonic | Class 2 | Endo Ultrasonic Activator ; Ultra Smart | 2023 | 14 |
| Syringe, Cartridge | Class 2 | Dental Anesthesia Booster; GENI, GENI Pro, GENI Pro+ | 2024 | 3 |
| Unit, Suction Operatory | Class 1 | Dental Aerosol Suction System; C-AS; C-AS1 | 2020 | 23 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243921 | 2025-04-11 | EBZ | Traditional | This company |
| K220179 | 2023-09-22 | EFB | Traditional | This company |
| K220829 | 2023-05-18 | EKX | Traditional | This company |
| K222096 | 2023-03-23 | ELC | Traditional | This company |
| K220826 | 2022-12-08 | EBZ | Traditional | This company |
| K220831 | 2022-09-27 | EBW | Traditional | This company |
| K212178 | 2022-07-20 | LQY | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Employees | 201-500 |
| Main products | Dental handpieces, Endodontic equipment, LED curing lights, Teeth whitening systems, Dental implant motors |
| Certifications | ISO, CE |
| Export markets | 120+ 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.
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