Duns Number:448015938
Device Description: Telio CAD Disc, Colado CAD CoCr4 Disc, IPS e.max ZirCAD Multi Disc, SR Vivodent CAD Disc, Telio CAD Disc, Colado CAD CoCr4 Disc, IPS e.max ZirCAD Multi Disc, SR Vivodent CAD Disc, ProArt CAD Model Disc, IvoBase CAD Disc, ProArt CAD Splint Disc, ProArt CAD Try-In Disc, ProArt CAD Wax yellow Disc, IvoBase CAD Bond Monomer, IvoBase CAD Bond Polymer, var. accessories
Catalog Number
690298AN
Brand Name
Telio CAD
Version/Model Number
690298AN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 04, 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
fae4078b-75f3-4a6e-9d23-8ca9f733861a
Public Version Date
February 07, 2022
Public Version Number
4
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 |