Manufacturer registered with FDA
Foshan COXO Medical Instrument Co., Ltd.
Foshan, China. Lists 16 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 16
- Brands and models
- 103
- 510(k) clearances
- 62022–2025
- Markets registered in
- 13301 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 13 markets
Where regulators' registries name Foshan COXO Medical Instrument Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Foshan COXO Medical Instrument Co., Ltd. | 6 clearances | 2022–2025 | Below |
| South Korea | MFDS | Manufacturer | Foshan COXO Medical Instrument Co., Ltd.FOSHAN COXO MEDICAL INSTRUMENT CO.,LTD · Foshan COXO Medical Instrument Co.,Ltd · +2 | 59 | 2008–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.FOSHAN COXO MEDICAL INSTRUMENT CO., LTD | 54 | 2015–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Foshan COXO Medical Instrument Co., Ltd. | 46 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | FOSHAN COXO MEDICAL INSTRUMENT CO., LTDFOSHAN COXO MEDICAL INSTRUMENT CO., LTD. · Foshan COXO Medical Instrument Co. Ltd. | 31 | 2012–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | FOSHAN COXO MEDICAL INSTRUMENT CO., LTD. | 24 | 2018–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | FOSHAN COXO MEDICAL INSTRUMENT Co; Ltd.Foshan COXO Medical Instrument Co, Ltd · Foshan COXO Medical Instrument Co. Ltd. · +1 | 21 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Foshan Coxo Medical Instrument Co Ltd | 19 | 2014–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Foshan Coxo Medical Instrument Co., Ltd | 16 | 2024–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | FOSHAN COXO MEDICAL INSTRUMENT CO., LTDFOSHAN COXO MEDICAL INSTRUMENT CO LTD | 13 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Foshan COXO Medical Instrument Co., Ltd | 11 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.Foshan COXO Medical Instrument Co., Ltd. · FOSHAN COXO MEDICAL INSTRUMENT CO., LTD | 6 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Foshan COXO Medical Instrument CO., LTD. | 1 | — | 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 Foshan COXO Medical Instrument 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 |
|---|---|---|---|---|
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | LED Curing Light; DB686 NANO, DB686 SWIFTLED Curing Lights; DB686 HALO | 2022 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Air Motors; CX235-3B, CX235-3C, CX235-3FDental Electrical Motors; C-PUMA MASTERDental Implantation Systems; C-Sailor ProGeared Angle Handpieces; CX235-1B, CX235-1C, CX235-1F, CX235-1G, CX235C1, CX235C2, CX235C3Geared Angle Handpieces; CX235C4, CX235C5, CX235C6, CX235C7, CX235C8, CX235-2S, CX235-2S1High-Speed Air Turbine Handpieces; CX207-C, CX207-C-2, CX207-G, CX207-W, CX207-W-2High-Speed Air Turbine Handpieces; CX207, CX207-2, CX207-A, CX207-A-2, CX207-B, CX207-B-2Straight Handpieces; CX235-2, CX235-2A, CX235-2B, CX235-2F, CX235-2G, CX235-2C, CX235-2S2 | 2022 |
| Ultraviolet DetectorEAQ · Class 2 | — | Maker | LED Curing Lights; DB686 HALO | 2025 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Dental Operating Lights; CX249-21; CX249-22; CX249-23; CX249-24 | 2020 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | Dental Aerosol Suction System; C-AS; C-AS1 | 2020 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Dental Electrical Motors; C-PUMA MASTERDental Implantation Systems; C-Sailor Pro | 2022 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Teeth Whitening Accelerator; C-Bright, C-Bright Ia | 2026 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Air Motors; CX235-3B, CX235-3C, CX235-3FGeared Angle Handpieces; CX235-1B, CX235-1C, CX235-1F, CX235-1G, CX235C1, CX235C2, CX235C3Geared Angle Handpieces; CX235C4, CX235C5, CX235C6, CX235C7, CX235C8, CX235-2S, CX235-2S1High-Speed Air Turbine Handpieces; CX207-C, CX207-C-2, CX207-G, CX207-W, CX207-W-2High-Speed Air Turbine Handpieces; CX207, CX207-2, CX207-A, CX207-A-2, CX207-B, CX207-B-2Straight Handpieces; CX235-2, CX235-2A, CX235-2B, CX235-2F, CX235-2G, CX235-2C, CX235-2S2 | 2023 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Maker | Amalgamator; DB338 | 2020 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Endodontic Obturation Systems; C-FILL; C-FILL MINI | 2021 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Dental Anesthesia Booster; GENI, GENI Pro, GENI Pro+ | 2024 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Dental Root Canal Instruments;C-File Flow L,C-File Mini,C-File Re,C-File Blue,C-File One SuperDental Root Canal Instruments;C-File,C-File Pro,C-File Pilot,C-File Gold,C-File One Plus,C-File One Pro,C-File PlusF1VK-21,F1VK-25,F1VK-31F2VK-21,F2VK-25,F2VK-31F3VK-21,F3VK-25,F3VK-31F4VK-21,F4VK-25,F4VK-31F5VK-21,F5VK-25,F5VK-31S1VK-21,S1VK-25,S1VK-31S2VK-21,S2VK-25,S2VK-31SXVK-19 63 more1002-21,1002-25,1002-311003-21,1003-25,1003-311004-21,1004-25,1004-311202V-21,1202V-25,1202V-311302-21,1302-25,1302-311502-21,1502-25,1502-311503-21,1503-25,1503-311504-21,1504-25,1504-311505-21,1505-25,1505-311506-181506K-21,1506K-25,1506K-311510VK-191602V-21,1602V-25,1602V-311704-21,1704-25,1704-311708K-101708VK-191712VK-191805-21,1805-25,1805-311902-21,1902-25,1902-312002-21,2002-25,2002-312003-21,2003-25,2003-312004-21,2004-25,2004-31,2004-162006K-21,2006K-25,2006K-31,2006K-162007V-21,2007V-25,2007V-31,2007V-222007VH-21,2007VH-25,2007VH-312008VK-192502-21,2502-25,2502-312504K-21,2504K-25,2504K-31,2504K-162506K-162506V-21,2506V-25,2506V-312506VH-21,2506VH-25,2506VH-312506VK-21,2506VK-25,2506VK-312507V-21,2507V-25,2507V-312507VH-21,2507VH-25,2507VH-312508V-182508VK-193002-21,3002-25,3002-313004K-21,3004K-25,3004K-31,3004K-163006K-163006V-21,3006V-25,3006V-313006VH-21,3006VH-25,3006VH-313006VK-21,3006VK-25,3006VK-313008VK-193009V-163502-21,3502-25,3502-313504K-21,3504K-25,3504K-313506V-21,3506V-25,3506V-313506VH-21,3506VH-25,3506VH-313506VK-21,3506VK-25,3506VK-314002-21,4002-25,4002-314004K-21,4004K-25,4004K-314006VK-21,4006VK-25,4006VK-314502K-21,4502K-25,4502K-314504K-21,4504K-25,4504K-314506VK-21,4506VK-25,4506VK-315002K-21,5002K-25,5002K-315004K-21,5004K-25,5004K-315006VK-21,5006VK-25,5006VK-315504VK-21,5504VK-25,5504VK-316002K-21,6002K-25,6002K-316004VK-21,6004VK-25,6004VK-317002K-21,7002K-25,7002K-318002K-21,8002K-25,8002K-31 | 2026 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | Endo Motor; C-Smart-I Pro, C-SMART-I PILOT, C-Smart-mini, C-SMART-MINI AP | 2023 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | Endo Ultrasonic Activator ; Ultra Smart | 2023 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Maker | Dental Electrical Motors; C-PUMA MASTERDental Implantation Systems; C-Sailor Pro | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant Torque Wrench; C-TW1,C-TW2 | 2024 |
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 Foshan COXO Medical Instrument Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Apr 2025 | K243921 | LED Curing Lights (DB686 HALO) | EBZ Ultraviolet Activator for Polymerization |
| 22 Sep 2023 | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | EFB Dental Air-Powered Handpiece |
| 18 May 2023 | K220829 | Endo Motor | EKX Ac-Powered Direct Drive Handpiece |
| 23 Mar 2023 | K222096 | Endo Ultrasonic Activator | ELC Ultrasonic Scaler |
| 8 Dec 2022 | K220826 | LED Curing Light | EBZ Ultraviolet Activator for Polymerization |
| 27 Sep 2022 | K220831 | Dental Implantation Systems, Dental Electrical Motors | EBW Handpiece and Cord Foot Controller |
Some of these clearances are listed with FDA today by another company: Onvet Medical Canada Inc. (3), Voco GmbH (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.FDA reg. 3014953747 | Foshan Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10075245). 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.