Duns Number:195544965
Device Description: A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use do A mixture of 5% sodium fluoride in a resin carrier, packaged in a convenient single-use dose for easy application
Catalog Number
-
Brand Name
CariFree Fluoride Varnish
Version/Model Number
CTx2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 13, 2022
Issuing Agency
In GS1
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
33bd56a7-1dbb-4c27-85eb-e1a495590586
Public Version Date
February 11, 2022
Public Version Number
3
DI Record Publish Date
March 03, 2021
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |