Duns Number:005209325
Device Description: 5mL bottle - Dentin desensitizing liquid formula.
Catalog Number
-
Brand Name
HurriSeal Dentin Desensitizer 5mL
Version/Model Number
5mL bottle
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2020
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
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
76441824-1fca-4596-81ba-03cfe3287e98
Public Version Date
November 05, 2020
Public Version Number
6
DI Record Publish Date
October 01, 2016
Package DI Number
02723797697144
Quantity per Package
72
Contains DI Package
01723797697145
Package Discontinue Date
November 04, 2020
Package Status
Not in Commercial Distribution
Package Type
case of 72
| 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 |