CamX Triton HD, SPECTRA Head

GUDID E247J27101

DÜRR DENTAL SE

Dental caries detector, optical induced fluorescence
Primary Device IDE247J27101
NIH Device Record Key4ff0e2a0-edc3-4f7f-8788-31fb721c88cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCamX Triton HD, SPECTRA Head
Version Model NumberJ2710
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
HIBCCE247J27101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBLLaser, Fluorescence Caries Detection

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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