FDA.reportPublic FDA data

510(k) K233053

Device
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
Applicant
Dental Imaging Technologies Corporation
510(k) number
K233053
Product code
MUH
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-21
Date received
2023-09-25
Regulation
872.1800
Classification name
System, X-Ray, Extraoral Source, Digital
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Anuradha Moholkar
Address
450 Commerce Dr. Quakertown PA US 18951 18951

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MUH#

510(k), Device, Applicant table
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K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.2024-10-11
K241649DUO1 and DUO2Zinnovi, Inc.2024-07-05
K232325RAYSCAN a-ExpertRay Co., Ltd.2024-04-18
K231660Digital image scanner of dentalJiangsu Dynamic Medical Technology Co., Ltd.2023-12-20
K232552TuxDeluxe (Size 1 6100B, Size 2 6101B)Tuxedo Imaging, LLC2023-10-20
K230998Digital Wireless Intraoral X-Ray SensorIray Imaging Technology (Haining) Limited2023-10-20
K230916WeSensorPicopack, Inc.2023-10-10
K232255EZSensor XHDQpix Solutions, Inc.2023-09-27
K232158GenX-CRGenoray Co., Ltd.2023-09-13
K231202QuickRayPRODenterprise International, Inc.2023-06-22