Duns Number:006309355
Device Description: Young D-Lish 5% Sodium Fluoride Varnish, 0.40mL each, Green Apple - Includes UltraBrush 2. Young D-Lish 5% Sodium Fluoride Varnish, 0.40mL each, Green Apple - Includes UltraBrush 2.0 applicator per dose unit
Catalog Number
295733
Brand Name
D-LISH
Version/Model Number
295733
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
K080814,K080814,K080814
Product Code
LBH
Product Code Name
VARNISH, CAVITY
Public Device Record Key
71f972f6-c52e-4dc2-ae7d-3de06c28f16d
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
20302730002274
Quantity per Package
14
Contains DI Package
00302730002270
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |