Duns Number:316803246
Device Description: Visalys Veneer Size S, Upper/OK 21/US9
Catalog Number
28421S
Brand Name
Visalys Veneer
Version/Model Number
28421S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 07, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K982692
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
eaf2bd1d-2d41-4e00-8559-4242eeb13a35
Public Version Date
March 08, 2022
Public Version Number
4
DI Record Publish Date
September 19, 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 | 27 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 248 |