Duns Number:099490679
Device Description: The Microlux Transilluminator is used for detecting Anterior and Posterior Caries. It also The Microlux Transilluminator is used for detecting Anterior and Posterior Caries. It also helps to visualize crown fractures, root canal orifice, and root fractures. Microlux applications include an accessory for Proximal Caries detection, and Oral Cancer Screening.
Catalog Number
620007
Brand Name
AdDent
Version/Model Number
Microlux
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062961
Product Code
NTK
Product Code Name
Caries Detector, Laser Light, Transmission
Public Device Record Key
62175719-d1dc-4b98-802a-c97be580d7da
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |