Duns Number:968801118
Device Description: Colgate PreviDent Varnish 5% Sodium Fluoride has a strong desensitizing action when applie Colgate PreviDent Varnish 5% Sodium Fluoride has a strong desensitizing action when applied to dental surfaces treating hypersensitivity quickly and easily. This product sets rapidly on contact with saliva, resulting in patient comfort and acceptance. PreviDent will leave a thin film on teeth after application.
Catalog Number
-
Brand Name
Colgate PreviDent Varnish Raspberry - unit dose
Version/Model Number
US04261A
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
-
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
e67bb591-e767-4702-9bd6-574f5bac6b83
Public Version Date
April 16, 2019
Public Version Number
1
DI Record Publish Date
April 08, 2019
Package DI Number
10038341451165
Quantity per Package
12
Contains DI Package
00038341451168
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |