Duns Number:005479970
Device Description: Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitenin Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and all other desensitizing needs.
Catalog Number
10-1017
Brand Name
KöR
Version/Model Number
KöR Complete Desensitizer - 5mL
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EJK
Product Code Name
Liner, Cavity, Calcium Hydroxide
Public Device Record Key
22859dfa-3389-483a-b74c-b4d20b7f94d5
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
March 06, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |