Duns Number:148312838
Device Description: Alpha-Flow® is a radiopaque fluoride containing light cure resin-based micro-hybrid flowab Alpha-Flow® is a radiopaque fluoride containing light cure resin-based micro-hybrid flowable composite. The specially formulated materials incorporates both a nano-sized filler for increased flexibility and superior polishability and a 0.7 micron filler for excellent strength and wear resistance. This special combination provides a material with extreme versatility for use in a wide range of procedures, including Class III and V cavity figurations and small Class I and II restorations. Alpha-flow® contains fluorescence to provide a duplication of the natural tooth surface. Kit Contains: 1 x 1.5g Composite syringe (Shade A3.5), 5 Syringe Applicator Tips
Catalog Number
103.0402.002
Brand Name
Alpha-Flow®
Version/Model Number
103.0402.002
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
K960667
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
091a8230-a58f-46b4-b3f6-d298b4ecd0fb
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 |