Duns Number:898067533
Device Description: Light-curing composite for all dental shades for use in anterior and posterior restoration Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities.The optical properties of Vittra APS Unique come from a fine balance between refractive indices of the dental structure versus that of the resin, which results in the propagation of the base color (dental remnant) through the resin structure. This effect causes the resin to "assume" (or transmit) the tooth color. It has a fundamental role, the loads, the well-balanced opacity of the product and the aesthetic of the APS system.
Catalog Number
4000055660
Brand Name
Vittra APS Unique
Version/Model Number
Caps
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K210231
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
af2dab1f-aeb5-407e-9eaa-d29545225974
Public Version Date
February 22, 2022
Public Version Number
1
DI Record Publish Date
February 14, 2022
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |