Duns Number:315830349
Device Description: Shape 98 mm, roundThe CoCr round blank for milling crowns, bridges and bars. With a Vicker Shape 98 mm, roundThe CoCr round blank for milling crowns, bridges and bars. With a Vickers hardness of 320 HV, this CoCr material can be milled and polished very well. Naturally, the material is free from beryllium and nickel.
Catalog Number
-
Brand Name
Tizian Blank NEM, 98 x 20 mm
Version/Model Number
220104
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
-
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
EJH
Product Code Name
Alloy, Metal, Base
Public Device Record Key
48b928bd-8022-451d-bf01-979f28891b78
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 08, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 390 |