Duns Number:001496777
Device Description: SenzAway is a gel designed to relieve sensitivity of teeth to cold, sweet and hot food and SenzAway is a gel designed to relieve sensitivity of teeth to cold, sweet and hot food and liquids. One application should relieve sensitivity of teeth immediately and will last at least three months (individual results may vary)
Catalog Number
-
Brand Name
SenzAway
Version/Model Number
1
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120176,K120176,K120176
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
42c278a9-8498-4107-949f-481d0b83b841
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 27, 2016
Package DI Number
50010705400451
Quantity per Package
16
Contains DI Package
70010705400455
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |