DEXIS Titanium Sensor-R

GUDID D090101329450

Dental Imaging Technologies Corporation

Dental digital imaging sensor, intraoral
Primary Device IDD090101329450
NIH Device Record Key432b527f-6399-491c-aad2-51552bb6b3d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEXIS Titanium Sensor-R
Version Model Number1.013.2945
Company DUNS800111106
Company NameDental Imaging Technologies Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD090101329450 [Primary]
HIBCCEKAV101329450 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem, X-Ray, Extraoral Source, Digital

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-14
Device Publish Date2022-03-04

Devices Manufactured by Dental Imaging Technologies Corporation

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