CamX Triton HD Handpiece

GUDID E247J25101

DÜRR DENTAL SE

Dental caries detector, optical induced fluorescence
Primary Device IDE247J25101
NIH Device Record Keyf668141d-7be4-440c-8410-7d13a98f18ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameCamX Triton HD Handpiece
Version Model NumberJ2510
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
HIBCCE247J25101 [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

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