Duns Number:148312838
Device Description: ALPHA-DENT® Self Cure Composite contains 63% by volume of a blend of radiopaque fillers. ALPHA-DENT® Self Cure Composite contains 63% by volume of a blend of radiopaque fillers. With its ideal mechanical properties exhibiting high compressive strength and low water sorption, it has become a best seller in its category. Available in one universal shade that blends well to the existing tooth structure yielding an esthetically pleasing restoration. Kit Contains: 5g Base Paste
Catalog Number
110.0104.001
Brand Name
ALPHA-DENT® Self Cure Composite
Version/Model Number
110.0104.001
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
K904812
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
b18ccba8-7b5f-434d-b236-9793ad3f365c
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 |