Duns Number:067488114
Device Description: A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all c A two-part silane system creating a stronger chemical bond to feldspathic porcelain, all ceramic restorations, and recommended for best adhesion to veneers, crowns and other ceramic restorations.Also use it for easy chair-side repairs to: porcelain-gold restorations, porcelain jackets, porcelain denture teeth, popped-out porcelain veneers or facings. Eliminates costly laboratory remakes. This non-toxic, non-irritating formula can be used in or out of the mouth.
Catalog Number
06-2010
Brand Name
FUSION Silane
Version/Model Number
B
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBO
Product Code Name
Denture Repair Kit
Public Device Record Key
bb980a97-5045-4691-9cfe-f3b96a79d7b7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 26, 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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |