Duns Number:148312838
Device Description: Alpha-Core® DC is a highly filled radiopaque, dual cure composite in an Automix Delivery S Alpha-Core® DC is a highly filled radiopaque, dual cure composite in an Automix Delivery System designed specially for core build-ups and cementation of posts and pins. The material exhibits ideal mechanical properties with high compressive and tensile strength yet maintaining a dentin like feel when cutting. Its ideal handling characteristics allows for direct placement of that material with Intra Oral Tips. Kit Contains: 50g Cartridge (Shade Blue), 10 Automix Tips, 10 Intra Oral Tips
Catalog Number
122.0004.002
Brand Name
Alpha-Core® DC
Version/Model Number
122.0004.002
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
K070191
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
b05f42d7-92e6-45a5-b28f-fad3f4aec4d7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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. | 183 |