Duns Number:148312838
Device Description: Alpha-Pro® White Varnish contains 5% sodium fluoride. It is used in the treatment of denta Alpha-Pro® White Varnish contains 5% sodium fluoride. It is used in the treatment of dental and post-operative sensitivity. Alpha-Pro White Varnish when applied practically becomes invisible, unlike traditional varnishes that cause unsightly yellow coloring of the teeth. Alpha-Pro White Varnish sets immediately on contact with saliva, leaving a smooth, thin layer. Kit Contains: 50 x 0.5ml Jars (Strawberry), 50 Applicator Brushes, Patient Instruction Pad, 50 "Keep Smiling" Stickers
Catalog Number
407.0701.002
Brand Name
Alpha-Pro® White Varnish
Version/Model Number
407.0701.002
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
K124025,K124025
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
57ef6689-ccf3-4f46-af72-4845fb7af252
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 183 |