Duns Number:968801118
Device Description: Colgate Profesional Sensitivity Relief Serum is designed to provide rapid sensitivity reli Colgate Profesional Sensitivity Relief Serum is designed to provide rapid sensitivity relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. The product is directly applied to any sensitive teeth with the fingertip and gently massaged for 1 minute. Pea-sized amount should be used on each direct application and repeated as needed on daily basis
Catalog Number
-
Brand Name
Colgate Profesional Sensitivity Relief Serum Tube
Version/Model Number
US06793A
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
d4d486ac-5d8d-4baf-8c3c-aa271eb84eaf
Public Version Date
January 26, 2021
Public Version Number
1
DI Record Publish Date
January 18, 2021
Package DI Number
00035000983749
Quantity per Package
10
Contains DI Package
00035000977786
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |