Not currently registered with FDA under this name

Hefei Dentafilm Medical Equipment Co., Ltd.

Hefei, 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—

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Hefei Dentafilm Medical Equipment 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	Hefei Dentafilm Medical Equipment Co., Ltd.	1 clearances	2022–2022	Below
Peru	DIGEMID	Manufacturer	HEFEI DENTAFILM MEDICAL EQUIPMENT 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 Hefei Dentafilm Medical Equipment Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
2 Mar 2022	K214091	Dental Image Plate Scanner, Model DFC-4T-SMART	MUH Digital Extraoral Source X-Ray System

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.