CS MODEL+ 594483

GUDID 00693856000302

LICENCE CS MODEL+ V5 ALIGNER CAPABILITY

Dental Imaging Technologies Corporation

CAD/CAM software
Primary Device ID00693856000302
NIH Device Record Key552cc0b4-b33a-4e00-abef-60c029fa5739
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS MODEL+
Version Model Number594483
Catalog Number594483
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100693856000302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNNOrthodontic Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-21
Device Publish Date2023-12-13

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+2023-12-21LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
00693856000302 - CS MODEL+2023-12-21 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
D090800025720 - DEXIS Ti2 Sensor2023-12-20

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