Data / Medical devices / China / Foshan Soco Precision Instrument Co.,ltd.
Foshan Soco Precision Instrument Co.,ltd.: FDA-registered device maker in Foshan Guangdong, China, 1 510(k) clearance
Foshan Soco Precision Instrument Co.,ltd. is registered with the FDA (registration 3009391651) in Foshan Guangdong, China. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 12, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009391651
- Address
- 3-5 FL. Bldg 4, District A and 5 FL. Bldg 3, District A Guangdong New Light Source Industrial Base Luocun, Shishan Town, Nanhai District, Foshan Guangdong, China, 528226
- Owner or operator
- Foshan SOCO Precision Instrument Co.,Ltd. (10090650)
- Roles
- Manufacturer
- First device listed
- April 23, 2024
- Registered through
- 2027
- Brand names listed
- 1002,1202,1302,1502,1602,1902,2002,2502,3002,3502,4002, 1004,1504,1704,2004,2504,3004,3504,4004,4504,5004, 1505,1805,4505,1506,2006,2106,2506,3006,3506,4006,4506,5006, 2007,2507,3007,3507,1708,2508,3008,3508,1712, 4502,5002,1003,1503, 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-S, Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpieces:SCHD17-S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Manufacturer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Manufacturer | accessdata.fda.gov |
| Light, Microscope | IBJ | 1 | Manufacturer | accessdata.fda.gov |
| Light, Surgical Headlight | EBA | 1 | Manufacturer | accessdata.fda.gov |
| Loupe, Diagnostic/Surgical | FSP | 1 | Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 12, 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 | Substantially Equivalent | Foshan Soco Precision Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Light, Microscope
- All makers of File, Pulp Canal, Endodontic
- All makers of Light, Surgical Headlight
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of Handpiece, Air-Powered, Dental
- All makers of Loupe, Diagnostic/Surgical
Updated November 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.