Duns Number:789664455
Device Description: Alphaseal is a visible light cured cavity liner. It has a light paste consistency to facil Alphaseal is a visible light cured cavity liner. It has a light paste consistency to facilitate the application. OUTSTANDING FEATURES OF THE PRODUCT:• Fast and easy to apply • Economical • Compatible with all restoratives and cements • Mechanically strong and insoluble in oral fluids • Long shelf-life; no refrigeration required • Resistant to etching agents • X-ray opaque • Simplified handling; direct to tooth application
Catalog Number
1021
Brand Name
Alphaseal Liner
Version/Model Number
1021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
dcf583a2-dffd-40c5-84b5-9663d50ccbbe
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |