Duns Number:320744915
Device Description: Highly esthetic permanent composite luting cement. Veneer cementation with added value. Co Highly esthetic permanent composite luting cement. Veneer cementation with added value. Content: 1 syringe @ 6g Esthetic resin cement, accessories. Color: White.
Catalog Number
213044
Brand Name
Vitique
Version/Model Number
213044
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
78fa0929-7899-4a3d-8d91-b6e39b72c375
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 |