Duns Number:148312838
Device Description: Alpha II® AP is a radiopaque fluoride containing light-cure micro-hybrid restorative compo Alpha II® AP is a radiopaque fluoride containing light-cure micro-hybrid restorative composite. The special combination of fillers form a material that is extremely durable and wear-resistant; making it ideal for Class I and II restorations yet highly polishable for use in all Class III, IV and V restorations. Alpha II® AP has optimal handling characteristics. The material can be easily manipulated without sticking to your instruments. Alpha II® contains fluorescence to provide a duplication of the natural tooth surface. Kit contains: 15 x 0.30g Composite Unit Dose (Shade Incisal)
Catalog Number
102.1902.002
Brand Name
ALPHA II® AP
Version/Model Number
102.1902.002
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
Yes
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
K904813,K904813
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
600e0d15-8004-46cc-a03f-bfcb1479b4d0
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 |