Duns Number:316699578
Device Description: Syringe 4g A2GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative materia Syringe 4g A2GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterised by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness.
Catalog Number
2597
Brand Name
GrandioSO x-tra
Version/Model Number
2597
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
K181312
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
ae0ac6a8-b615-45cc-8fe4-702770556fc3
Public Version Date
September 24, 2018
Public Version Number
1
DI Record Publish Date
August 24, 2018
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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |