Duns Number:006309355
Device Description: VarnishAmerica 5% Sodium Fluoride Varnish, 0.4mL each, White Bubblegum, with Xylitol - Inc VarnishAmerica 5% Sodium Fluoride Varnish, 0.4mL each, White Bubblegum, with Xylitol - Includes Blue Ultrabrush
Catalog Number
07-0120
Brand Name
Varnish America
Version/Model Number
07-0120
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
922117ac-8753-4824-9216-193e88dc148a
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
10302730002291
Quantity per Package
200
Contains DI Package
00302730002294
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 | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |