Duns Number:344231006
Device Description: Ti6Al4V based dental alloy for milling, grade 5, Dimension: 99,5 mm x 14 mm
Catalog Number
-
Brand Name
Kera Ti5-Disc 99,5 x 14 mm
Version/Model Number
T10045114
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
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
b14fcb37-fed2-4428-9129-bfd56cbad2f0
Public Version Date
February 14, 2020
Public Version Number
1
DI Record Publish Date
February 06, 2020
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. | 87 |