Duns Number:002863526
Device Description: Advantage Arrest Silver Diamine Fluoride 38% 3 ml dropper bottle
Catalog Number
635000030
Brand Name
Advantage Arrest
Version/Model Number
3 ml 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
96ac417c-abb4-4a57-a3b9-75ef7903f333
Public Version Date
December 29, 2020
Public Version Number
1
DI Record Publish Date
December 21, 2020
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 |