CamX Triton HD, Cam Spectra

GUDID E247J25001

DÜRR DENTAL SE

Dental caries detector, optical induced fluorescence
Primary Device IDE247J25001
NIH Device Record Keyee75bcc1-8a56-416b-89d9-b7dc28d9d395
Commercial Distribution StatusIn Commercial Distribution
Brand NameCamX Triton HD, Cam Spectra
Version Model NumberJ2500
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
HIBCCE247J25001 [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

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).
E247G8800 - ScanX Swift 2.02023-03-07 Dental Image Plate Scanner
E247G8900 - ScanX Swift View 2.02023-03-07 Dental Image Plate Scanner
E247E7300A10 - VisionX2022-04-04 VisionX version 3.0.x
E247A78610 - ProVecta 3D Prime Ceph2022-03-14 X-Ray System
E247J21101 - CamX Elara2022-03-14
E247J27111 - CamX Cam Interchangeable Head2022-03-14

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