Duns Number:830016148
Device Description: 3M™ ESPE™ CavityShield™ 5% Sodium Fluoride Varnish Mixed Dentition Trial Pack - Bubble Gum 3M™ ESPE™ CavityShield™ 5% Sodium Fluoride Varnish Mixed Dentition Trial Pack - Bubble Gum Flavor, 12143
Catalog Number
12143
Brand Name
CavityShield™
Version/Model Number
12143
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
dd2922af-ce49-483b-ac9e-87064b9c763f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 | 274 |
2 | A medical device with a moderate to high risk that requires special controls. | 444 |
U | Unclassified | 7 |