Duns Number:096191093
Device Description: 5% Sodium Fluoride Varnish with TCP Caramel Unidose 50/bx. - MARK3
Catalog Number
-
Brand Name
MARK3
Version/Model Number
7102
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K982915,K982915
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
3f9ecd83-69bb-4cc5-a39f-4d9251efd990
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 13, 2018
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 | 96 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 93 |
| U | Unclassified | 1 |