Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021551875

FEI Number

3021551875

Entity Name

Dental Imaging Technologies Corporation

City/State/Country

Quakertown, PA, US

Establishment Address

450 Commerce Drive, Quakertown, PA 18951, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Dental Imaging Technologies Corporation (Owner Number: 9007915)

Owner / Operator Contact Address

450 Commerce Drive, --, Quakertown, PA 18951, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173319

PMA Number

N/A

All Registered Proprietary Names

DEXIS IXS Size 2 Intraoral Sensor DEXIS Ti2 Intraoral Sensor DEXIS IXS Size 1 Intraoral Sensor DEXcam4 HD Dexis Titanium DEXIS IXS Size 1 DEXIS IXS Size 2 NOMAD Pro 3 DEXIS Imaging Suite DEXIS Software NOMAD Pro 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2023-12-05
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2015-04-02
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2019-09-20
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2026-03-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2010-10-22
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	2020-02-05
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2020-03-03

Official Correspondent

Erika Martin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Dental Imaging Technologies Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021551875. Last updated year: 2026. Please use registration number 3021551875 when referencing this establishment in official correspondence.