Duns Number:448015938
Device Description: Telio Desensitizer Refill 50x0.1g
Catalog Number
701960
Brand Name
Telio Desensitizer
Version/Model Number
701960
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
EMA
Product Code Name
CEMENT, DENTAL
Public Device Record Key
e8774e9b-fad6-4d06-9565-6c893fd9c148
Public Version Date
March 17, 2022
Public Version Number
4
DI Record Publish Date
November 11, 2020
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 | 131 |
2 | A medical device with a moderate to high risk that requires special controls. | 12768 |