Duns Number:002863526
Device Description: Advantage Arrest Silver Diamine Fluoride 38% 8 ml dropper bottle.
Catalog Number
635000100
Brand Name
Advantage Arrest
Version/Model Number
8ml Bottle
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
K102973
Product Code
PHR
Product Code Name
Diammine Silver Fluoride Dental Hypersensitivity Varnish
Public Device Record Key
92423745-8f5e-4514-9bbb-18df57a33c93
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 26, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |
| U | Unclassified | 5 |