Duns Number:320744915
Device Description: Accessory kit for definitive cementation of veneers. Veneer cementation with added value. Accessory kit for definitive cementation of veneers. Veneer cementation with added value. Content: 1 bottle @ 3 ml Silane Adhesive, 1 bottle @ 3 ml Silane Activator, 1 bottle @ 5 ml Bond, 1 syringe @2 ml Etching Gel, accessories.
Catalog Number
213082
Brand Name
Vitique
Version/Model Number
213082
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
K890464,K131248,K023649,K063444
Product Code
EBC
Product Code Name
Sealant, Pit And Fissure, And Conditioner
Public Device Record Key
e4833693-539d-492b-a3dc-fc5210b713c1
Public Version Date
May 14, 2019
Public Version Number
4
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 |