Manufacturer registered with FDA
Shenzhen Sinco Technology Co., Limited.
Shenzhen, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Shenzhen Sinco Technology Co., Limited. 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 | Shenzhen Sinco Technology Co., Limited. | 3 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Shenzhen Sinco Technology Co.Limited | 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 Shenzhen Sinco Technology Co., Limited. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Oral Irrigator: 1001, 1002,1003, 1004, 1005, 1006, 1007, 1008, 1009, 1010, 1201, 1301, 1302, 1303, 1304, 1305Teeth Cleaner: J001, J002, J003, J004, J005, J006, J007, J008, J009, J010 | 2024 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Brushhead: EB17-X, EB18-X, EB20-X, EB25-X, EB28-X, EB50-X, EB52-X, EB60-X, SB-17A, EB-10A, HX614, HX664, HX9034, HX924Brushhead: HX934 | 2024 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric Toothbrush: 100, 101, 102, 105, 108, 128, X-2, X-3, B001, B002, 201, 202, 204, 205, 206, 208, SC-208, 210Electric Toothbrush: 2010, 2011 2012, 2013, 2014, 2015, 8001, 8002, 8003, 8004, 8005, 8006Electric Toothbrush: 211, 212, 218, 310, 310C, 311, 312, 313, 315, 316, 317, 318, 319, 320, 321, 325, 326, 328, 329Electric Toothbrush: 320, 500, 501, 502, 503, 505, 506, SC-506, 506C, 507, 508, 509, 510, 511, 512, 513, 514, 515, 516Electric Toothbrush: 517, 518, 519, 520, 521, 522, 523, 524, 525, 601, 602, 603, 604, 605, 606, 607, 608, 609Electric Toothbrush: 602, 603, 604, 605, 606, 608, 618Electric Toothbrush: 610, 1999, 2000, 2001, 2002, 2003, C2003A, C2003B, 2004, 2005, 2006, 2006A, 2007, 2008, 2009 | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN SINCO TECHNOLOGY CO., LIMITED.FDA reg. 3013185096 | Shenzhen Guangdong, China | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090858). 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.