Duns Number:001344381
Device Description: Colgate ProRelief is designed for the management of sensitive teeth. The product is appli Colgate ProRelief is designed for the management of sensitive teeth. The product is applied to any sensitive teeth with the Pro-Relief sonic applicator which the head is filled with serum and massaged on to each sensitive tooth.
Catalog Number
-
Brand Name
Colgate Prorelief Sensitivity Relief Serum
Version/Model Number
US05562A
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)
-
Over the Counter (OTC)
Yes
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
877de8e7-a804-4d56-98a9-d622f535cd8b
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
May 31, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |