Duns Number:564251911
Device Description: Content: 1 piece Height: 18 mm Sinternit (cobalt-chrome alloy) especially conceived for th Content: 1 piece Height: 18 mm Sinternit (cobalt-chrome alloy) especially conceived for the production of dowels. Veneering with ceramic possible.
Catalog Number
-
Brand Name
SINTERNIT POSTCORE 98H18 with step
Version/Model Number
MEAU98S18
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
453fa0c3-8104-46e9-a7b2-90b746994f7c
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 |