Duns Number:067488114
Device Description: Prevents movement of the restoration during cementation. Allows for proper placement, posi Prevents movement of the restoration during cementation. Allows for proper placement, positioning, and seating of veneers, with gentle and even distribution of pressure. Holds restoration securely during try-in, while contacts are checked with floss. Allows clear visibility of working field. Removes the need for touching the restoration with a glove. This prevents possible contamination of saliva or glove powder. Veneer Styx are autoclavable. Tips are disposable (Single use per patient).
Catalog Number
45-1010
Brand Name
Veneer Styx Kit
Version/Model Number
1x Veneer Styx, 6x Blue Tips
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
-
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
DZN
Product Code Name
Instruments, Dental Hand
Public Device Record Key
0d9b1e83-d14a-4607-8975-9a7a8ca423ce
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
September 10, 2019
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 |