CS 3800 Wired 5943725

GUDID 60192155943720

CS 3800 3D I/O SCANNER WIRED

CARESTREAM DENTAL LLC

Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental CAD/CAM system, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside Dental milling system, CAD/CAM, chairside
Primary Device ID60192155943720
NIH Device Record Keyb01c6cbd-9630-4e17-bed5-68ea28848e89
Commercial Distribution StatusIn Commercial Distribution
Brand NameCS 3800 Wired
Version Model Number5943725
Catalog Number5943725
Company DUNS019796106
Company NameCARESTREAM DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS160192155943720 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-02-21
Device Publish Date2021-04-09

Devices Manufactured by CARESTREAM DENTAL LLC

60192155945076 - RIOSensor+2024-01-25 RIOSensor+ Size 1
60192155945083 - RIOSENSOR+2024-01-25 RIOSENSOR+ SIZE 2
60192155944864 - CS 8200 3D Access2023-12-20 CS 8200 3D ACCESS
60192155944833 - DENTRA III2023-06-12 DENTRA III SIZE 1
60192155944840 - DENTRA III2023-06-12 DENTRA III SIZE 2
60192155944543 - Swissmeda powered by Carestream Dental2022-10-31 Swissmeda powered by Carestream Dental
60192155943720 - CS 3800 Wired2022-02-21CS 3800 3D I/O SCANNER WIRED
60192155943720 - CS 3800 Wired2022-02-21 CS 3800 3D I/O SCANNER WIRED
60192155944482 - CS Model+2021-11-15 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.