Duns Number:002863526
Device Description: FluoriMax Varnish Flow Through Ampoule Mint Shipper
Catalog Number
-
Brand Name
FluoriMax Mint
Version/Model Number
Shipper
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
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
K131376
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
ceeec0bc-50e4-4fc4-8663-ca6ec505b55b
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2017
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 |