Registered with FDA

Xtechdental Inc.

Fort Lee, NJ, United States. Lists 2 dental device types with FDA across 1 registered establishment.

FDA owner/operator10095904

Device types listed: 2
Brands and models: 10
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1United States

Devices listed with FDA

What Xtechdental Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Digital Extraoral Source X-Ray SystemMUH · Class 2	Dental X-ray units	Lister	Digital Intraoral Imaging Plate SystemF200 IMAGE PLATE SYSTEM	2026
Dental Computed Tomography X-RayOAS · Class 2	Dental CBCT	Lister	Dental Computed Tomography X-ray SystemMatrix7000Matrix7800Rubik Series CBCTRubik X1Rubik X3Rubik XSmartXSmart	2026

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

Also lists devices cleared under other names

Xtechdental Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Fussen Technology Co., Ltd (1), Fsusen Technology Co., Ltd. (1).

Decided	510(k)	Device	Applicant	Device type
13 Nov 2025	K251842	Dental Computed Tomography X-ray System	Fussen Technology Co., Ltd	OAS Dental Computed Tomography X-Ray
5 Dec 2019	K192766	Digital Intraoral Imaging Plate System	Fsusen Technology Co., Ltd.	MUH Digital Extraoral Source X-Ray System

Registered establishments

Establishment	Location	What it does
XTECHDENTAL INCFDA reg. 3045129740	Fort Lee, NJ, United States	Complaint file establishment

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10095904). 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.