Duns Number:001804074
Device Description: Fluoride Varnish, Box of 100 single dose (0.40ml) (Bubblegum flavor)
Catalog Number
20021256
Brand Name
Waterpik UltraClear Fluoride Varnish (Bubblegum)
Version/Model Number
20021256
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
Yes
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
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
1a49e463-ad50-40e2-ac13-a0aedfb0c38c
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
August 12, 2016
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 | 293 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 56 |