Duns Number:005209325
Device Description: Dentin desensitizing liquid formula. 1 x 5mL bottle in box
Catalog Number
-
Brand Name
HurriSeal Dentin Desensitizer 5mL
Version/Model Number
5mL bottle
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
K973002,K973002,K973002
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
4796aae7-46bf-4877-a546-4d365ceb8741
Public Version Date
November 05, 2020
Public Version Number
2
DI Record Publish Date
January 07, 2020
Package DI Number
20723797697140
Quantity per Package
72
Contains DI Package
10723797697143
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
72 count case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |