Duns Number:316699578
Device Description: Universal nanohybrid ORMOCER restorative material.This kit contains different shades of Ad Universal nanohybrid ORMOCER restorative material.This kit contains different shades of Admira Fusion, Admira Fusion x-tra and Futurabond U.
Catalog Number
2750
Brand Name
Admira Fusion
Version/Model Number
2750
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
K130486,K150784,K151956
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
3b745b66-0706-4614-bcd7-a3d3be979a24
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 396 |
| U | Unclassified | 5 |