Duns Number:067488114
Device Description: FUSION-Zr™ Try-in Paste allows the restoration to be temporarily placed in the patients mo FUSION-Zr™ Try-in Paste allows the restoration to be temporarily placed in the patients mouth for optimal color and placement matching before cementation.
Catalog Number
06-5605
Brand Name
FUSION-Zr - Try-in Paste
Version/Model Number
Opal White - 1.2ml Syringe
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
K073101
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
b898d0a0-24f4-423c-8622-7865b7012a1f
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 |