Duns Number:096010525
Device Description: NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Car NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. Blue Shade. Trial Size.
Catalog Number
57-013
Brand Name
SciPharm NewCore, Core Build-Up Restorative Automix
Version/Model Number
SP 57-013 T
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
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
K810479
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
ae12a2d6-010b-4f77-80fb-37da23025427
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 09, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 476 |