CS Model+ 5944483

GUDID 60192155944482

LICENCE CS MODEL+ V5 ALIGNER CAPABILITY

CARESTREAM DENTAL LLC

CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software CAD/CAM software
Primary Device ID60192155944482
NIH Device Record Keye71d87b6-2007-45d6-8c14-2586c94f9973
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS Model+
Version Model Number5944483
Catalog Number5944483
Company DUNS019796106
Company NameCARESTREAM DENTAL LLC
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
GS160192155944482 [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 Date2021-11-15
Device Publish Date2021-11-05

On-Brand Devices [CS Model+]

60192155942716CS MODEL+
60192155944482LICENCE CS MODEL+ V5 ALIGNER CAPABILITY

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