Duns Number:067488114
Device Description: FUSION-Zr® Dual Cure Cement is self-adhesive. For permanent cementation of all-ceramic res FUSION-Zr® Dual Cure Cement is self-adhesive. For permanent cementation of all-ceramic restorations, Zirconia, Lithium Disilicate, CAD/CAM materials, veneers, crown & bridge, inlays/onlays, PFM, posts/fiber posts.
Catalog Number
06-5551
Brand Name
FUSION-Zr - Dual Cure Resin Cement
Version/Model Number
Opal White - 3.5 gm Syringe Evaluator
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
K132393
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
fd466d50-efca-4e82-8786-af7e39c53f59
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 05, 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 |