Duns Number:564251911
Device Description: Content: 1 piece Height: 22 mm Sinternit (cobalt-chrome alloy) for the production of singl Content: 1 piece Height: 22 mm Sinternit (cobalt-chrome alloy) for the production of single crowns, bridges, bars and telescopic crowns. It is suitable for monolithic restorations as well as structures of up to 14 units for veneering with ceramics. Info: our Sintermetall has a new name: Sinternit. Properties and range of applications remain unchanged
Catalog Number
-
Brand Name
SINTERNIT 106H22
Version/Model Number
MEAS10622
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
eff13baa-605f-4f3d-8732-58eea75dda2b
Public Version Date
July 28, 2022
Public Version Number
1
DI Record Publish Date
July 20, 2022
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 | 1369 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4845 |
| U | Unclassified | 3 |