Duns Number:096010525
Device Description: Visible Light-Cured, Highly Filled Composite Restorative for use Primarily in Class I and Visible Light-Cured, Highly Filled Composite Restorative for use Primarily in Class I and Class II Restorations. Custom Mini Kit. Spanish
Catalog Number
55-10
Brand Name
SciPharm CuRay Fil Light Cure Composite Resin
Version/Model Number
SP 55-10 S
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
K823510
Product Code
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
203b708d-32a1-494b-a394-0168fd8647fc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 18, 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 |