Duns Number:320744915
Device Description: Cementation system for definitive cementation of veneers. Veneer cementation with added va Cementation system for definitive cementation of veneers. Veneer cementation with added value. Content: 3 syringes @ 6g Esthetic resin cement, 3 syringes @ 3.9 g Try-In-paste, accessories. Resin-based dental luting material. 1 bottle @ 3ml Silane Adhesive, 1 bottle @ 3 ml Silane Activator, 1 bottle @ 5 ml Bond, 1 syringe @ 2 ml Etching Gel, accessories.
Catalog Number
213080
Brand Name
Vitique
Version/Model Number
213080
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
547b794c-c798-49c2-a4e3-ea34681fb055
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 |