Duns Number:043835081
Device Description: The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
Catalog Number
-
Brand Name
CamX Spectra Caries Detection Aid
Version/Model Number
G4100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090169,K090169,K090169
Product Code
NBL
Product Code Name
Laser,Fluorescence Caries Detection
Public Device Record Key
f3992f2f-b115-43d0-88be-03c7ba1a054b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
D678G40001
Quantity per Package
1
Contains DI Package
D678G41000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |