Duns Number:316699578
Device Description: highly flowable, light-curing, radiopaque nano-hybrid restorative materialThe set contains highly flowable, light-curing, radiopaque nano-hybrid restorative materialThe set contains 5 different shades of GrandioSOFlow, a shade guide and application cannulas type 44 and type 45.
Catalog Number
2585
Brand Name
GrandioSO Light Flow
Version/Model Number
2585
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
K200294,K200294
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
89b39789-a096-40f8-ac52-fe9a5c66d90a
Public Version Date
April 08, 2020
Public Version Number
1
DI Record Publish Date
March 31, 2020
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 |