EKAV101397190

GUDID D090101397190

Dental Imaging Technologies Corporation

Dental digital imaging sensor, intraoral
Primary Device IDD090101397190
NIH Device Record Key2c1cf8f4-0394-43ad-bbfa-a36e5c49f15d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEKAV101397190
Version Model Number1.013.9719
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 Datefalse
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
HIBCCD090101397190 [Primary]
HIBCCEKAV101397190 [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

D090100879340 - DEXIS 10 (DEXIS Imaging Suite)2024-03-20
D090800025750 - DEXIS Ti2 Sensor Kit2024-01-31 DEXIS Ti2 Kit, EN FR-CA
D090800025780 - DEXIS Ti2 Sensor Kit2024-01-31 DEXIS Ti2 Warranty Replacement NEW
D090800025790 - DEXIS Ti2 Sensor Kit2024-01-31 Upgrade Kit, Sensor to Ti2
D090800025800 - DEXIS Ti2 Sensor Kit2024-01-31 DEXIS Ti2 Warranty Replacement - R
D090800025840 - DEXIS Ti2 Sensor Kit2024-01-31 Upgrade Kit, Platinum to Ti2
00693856000302 - CS MODEL+2023-12-21 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
D090800025720 - DEXIS Ti2 Sensor2023-12-20

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