Manufacturer registered with FDA
Foshan SOCO Precision Instrument Co.,Ltd.
Foshan, China. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 48
- 510(k) clearances
- 12024–2024
- Markets registered in
- 828 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name Foshan SOCO Precision 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 SOCO Precision Instrument Co.,Ltd. | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | Foshan SOCO Precision Instrument Co.,Ltd. | 6 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | FOSHAN SOCO PRECISION INSTRUMENT CO., LTD | 5 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | FOSHAN SOCO PRECISION INSTRUMENT CO., LTD.Foshan SOCO Precision Instrument Co., Ltd. | 5 | 2019–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | FOSHAN SOCO PRECISION INSTRUMENT CO., LTD. | 4 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Foshan SOCO Precision Instrument Co., Ltd. | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Foshan SOCO Precision Instrument Co.LtdFoshan SOCO Precision Instrument Co., Ltd | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | FOSHAN SOCO PRECISION INSTRUMENT CO., LTD. | 1 | 2024–2024 | 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 SOCO Precision 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 |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Intra-oralmirrormodel:SCKJ01,SCKJ02,SCKJ03,SCKJ04,SCKJ05,SCKJ06,SCKJ07,SCKJ08 | 2026 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | Medical Headlightmodel:SCML05,SCML06 | 2026 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpieces: SCHD24-SDental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpieces:SCHD17-SDental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpiecess:SCHD16-SDental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpiecess:SCHD27-SDental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors, Straight Handpieces: SCHD05-SGeared Angle Handpieces: SCHB20Geared Angle Handpieces: SCHB4Geared Angle Handpieces: SCHB5Geared Angle Handpieces: SCHB64 8 moreGeared Angle Handpieces: SCHD05-CGeared Angle Handpieces: SCHD06-CGeared Angle Handpieces: SCHD16-CGeared Angle Handpieces: SCHD24-CGeared Angle Handpieces: SCHD27-CGeared Angle Handpieces: SCHD29-SGeared Angle Handpieces:SCHD17-CHigh-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22) | 2024 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpieces: SCHD24-SDental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpieces:SCHD17-SDental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpiecess:SCHD16-SDental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpiecess:SCHD27-SDental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors, Straight Handpieces: SCHD05-SGeared Angle Handpieces: SCHB20Geared Angle Handpieces: SCHB4Geared Angle Handpieces: SCHB5Geared Angle Handpieces: SCHB64 8 moreGeared Angle Handpieces: SCHD05-CGeared Angle Handpieces: SCHD06-CGeared Angle Handpieces: SCHD16-CGeared Angle Handpieces: SCHD24-CGeared Angle Handpieces: SCHD27-CGeared Angle Handpieces: SCHD29-SGeared Angle Handpieces:SCHD17-CHigh-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22) | 2024 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Dental Root Canal InstrumentSC,SC-PRO,SC plus,S-one plus,S-one pro,SX-F3,SC-GOLDSX,S1,S2,F1,F2,F31002,1202,1302,1502,1602,1902,2002,2502,3002,3502,40021004,1504,1704,2004,2504,3004,3504,4004,4504,50041505,1805,4505,1506,2006,2106,2506,3006,3506,4006,4506,50062007,2507,3007,3507,1708,2508,3008,3508,17124502,5002,1003,1503 | 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 SOCO Precision Instrument Co.,Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Nov 2024 | K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FOSHAN SOCO PRECISION INSTRUMENT CO.,LTD.FDA reg. 3009391651 | Foshan Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090650). 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.