Duns Number:448015938
Device Description: Telio CS CB A2, Mixing Tips, Telio CS Link Transparent, Mixing Tips, Telio CS Desensitizer Telio CS CB A2, Mixing Tips, Telio CS Link Transparent, Mixing Tips, Telio CS Desensitizer, Application Brushes, var. accessories
Catalog Number
628244AN
Brand Name
Telio CS
Version/Model Number
628244AN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 26, 2022
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
-
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
EBG
Product Code Name
CROWN AND BRIDGE, TEMPORARY, RESIN
Public Device Record Key
85a23103-3416-4b07-bb92-e64ab017bf1d
Public Version Date
January 27, 2022
Public Version Number
3
DI Record Publish Date
September 27, 2018
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 |