Duns Number:096010525
Device Description: DFV Desensitizing Varnish (Wonderful Varnish), Marshmallow flavor, is a fluoride-containin DFV Desensitizing Varnish (Wonderful Varnish), Marshmallow flavor, is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Catalog Number
70-24
Brand Name
DFV Desensitizing Varnish (Wonderful Varnish) Marshmallow
Version/Model Number
70-24
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192381
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
189438f0-639f-4096-a60a-73cc182e7e59
Public Version Date
January 27, 2022
Public Version Number
1
DI Record Publish Date
January 19, 2022
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |