Duns Number:830016148
Device Description: 3M™ Fast Release Varnish 5% Sodium Fluoride, 12158C, Caramel Flavor, 200 0.4 mL Unit Dose
Catalog Number
12158C
Brand Name
3M™
Version/Model Number
12158C
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
-
Product Code
LBH
Product Code Name
VARNISH, CAVITY
Public Device Record Key
f8a4b77f-0416-41c7-b928-4865c174970b
Public Version Date
October 21, 2022
Public Version Number
1
DI Record Publish Date
October 13, 2022
Package DI Number
50605861078547
Quantity per Package
5
Contains DI Package
10605861078549
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |