Duns Number:009260217
Device Description: Fluorilaq Squeeze Bubblegum with 5% Sodium Fluoride Varnish, 9.5 mL squeezable bottlev
Catalog Number
10420
Brand Name
Fluorilaq Squeeze Varnish Bubblegum
Version/Model Number
10420
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
-
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
K030488
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
2b1ca0e2-d65a-44d3-8ac6-d6c7d6d643c8
Public Version Date
March 04, 2019
Public Version Number
1
DI Record Publish Date
January 30, 2019
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 | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 57 |