Not currently registered with FDA under this name

Nanjing Jiahe Dental Technology Co., Ltd.

Nanjing, China. Named as applicant on 1 dental 510(k) clearance between 2022 and 2022. No establishment is registered with FDA under this exact name today.

1 clearance in five years
Device types listed
0
Brands and models
0
510(k) clearances
12022–2022
Markets registered in
21 registrations outside the US
Establishments
0—
2022: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Nanjing Jiahe Dental Technology Co., Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesEuropean Union: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantNanjing Jiahe Dental Technology Co., Ltd.1 clearances2022–2022Below
European UnionEUDAMEDManufacturerNanjing Jiahe Dental Technology co. LTD1—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 Nanjing Jiahe Dental Technology Co., Ltd. as the applicant.

Decided510(k)DeviceDevice type
20 Dec 2022K222308Al Smile AlignerNXC Sequential Aligner

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.