Duns Number:320744915
Device Description: Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with a Water soluble glycerin-free Try-in-paste for Veneer cementation. Veneer cementation with added value. Refill: Content: 1 syringe @ 3.9 g Try-in-paste, accessories. Color: TR.
Catalog Number
213053
Brand Name
Vitique
Version/Model Number
213053
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
-
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
K023649
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
f828d621-92b7-4a7d-a6e1-e4e905b1d999
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 143 |