Manufacturer registered with FDA

PDX Co., Ltd.

Anyang-Si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10096011Manufacturer1 clearance in five years

Device types listed: 1
Brands and models: 1
510(k) clearances: 12026–2026
Markets registered in: 1United States
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Devices listed with FDA

What PDX Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Extraoral with Timer X-Ray UnitEHD · Class 2	Dental X-ray units	Maker	nova	2026

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names PDX Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
27 May 2026	K260367	Portable Dental X-ray System Model PDX nova	EHD Extraoral with Timer X-Ray Unit

Registered establishments

Establishment	Location	What it does
PDX Co., Ltd.FDA reg. 3043564919	Anyang-Si Gyeonggi, South Korea	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10096011). 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.