CamX Triton HD, Cam

GUDID E247J26001

DÜRR DENTAL SE

Dental caries detector, optical induced fluorescence
Primary Device IDE247J26001
NIH Device Record Key55fd8272-5cc3-4b7e-8f36-24620c24bdf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCamX Triton HD, Cam
Version Model NumberJ2600
Company DUNS315563684
Company NameDÜRR DENTAL SE
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE247J26001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTKCaries Detector, Laser Light, Transmission

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-06
Device Publish Date2018-07-06

Devices Manufactured by DÜRR DENTAL SE

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E24721301004140 - VistaPosition Posterior2024-05-27
E24721301004150 - VistaPosition Endo2024-05-27
E24721301004160 - VistaPosition Bitewing2024-05-27
E247G37101 - VistaPosition Anterior/ Posterior Kit Titanium2024-05-27
E247G38101 - VistaPosition Anterior/ Posterior Kit2024-05-27
E247732480 - ScanX Barrier Envelope, 100 Pcs, Size 02023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
E247732482 - ScanX Barrier Envelope, 300 Pcs, Size 22023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).

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