Duns Number:099490679
Device Description: The Bio/Screen Oral Exam Light is a device intended for use as an adjunct to traditional o The Bio/Screen Oral Exam Light is a device intended for use as an adjunct to traditional oral examination to enhance the visualization of oral mucosal abnormalities.
Catalog Number
110090
Brand Name
AdDent
Version/Model Number
Bio/Screen
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
-
Product Code
NXV
Product Code Name
Diagnostic Light, Soft Tissue Detector
Public Device Record Key
18bda460-8b2c-4a73-8a80-44bb42688abe
Public Version Date
March 29, 2018
Public Version Number
2
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 |