Not currently registered with FDA under this name

Yofo Medical Technology Co., Ltd.

Hefei, China. Named as applicant on 2 dental 510(k) clearances between 2025 and 2026. No establishment is registered with FDA under this exact name today.

2 clearances in five years
Device types listed
0
Brands and models
0
510(k) clearances
22025–2026
Markets registered in
21 registrations outside the US
Establishments
0—
2025: 12026: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Yofo Medical Technology Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesEuropean Union: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantYofo Medical Technology Co., Ltd.2 clearances2025–2026Below
European UnionEUDAMEDManufacturerYofo Medical Technology 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

510(k) clearances

Clearances on which FDA names Yofo Medical Technology Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
4 Jun 2026K260662Dental Cone Beam Computed Tomography SystemOAS Dental Computed Tomography X-Ray
17 Apr 2025K243337Dental Cone Beam Computed Tomography SystemOAS Dental Computed Tomography X-Ray

Sources

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 of the most recent filing, which can be a US agent.