Not currently registered with FDA under this name

Nagy Oral Technology Qinhuangdao Co., Ltd.

Qinhuangdao, China. Named as applicant on 1 dental 510(k) clearance between 2026 and 2026. 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: 12026–2026
Markets registered in: 33 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name Nagy Oral Technology Qinhuangdao Co., Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: ChinaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Nagy Oral Technology Qinhuangdao Co., Ltd.	1 clearances	2026–2026	Below
European Union	EUDAMED	Manufacturer	Nagy Oral Technology Qinhuangdao Co., Ltd.	2	—	Pure Global AI
Peru	DIGEMID	Manufacturer	NAGY ORAL TECHNOLOGY QINHUANGDAO 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

510(k) clearances

Clearances on which FDA names Nagy Oral Technology Qinhuangdao Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
11 Jun 2026	K253052	Fluoride Varnish (Type A,Type C)	LBH Cavity Varnish

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.