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 Restoratives., Part A
Catalog Number
50-043
Brand Name
SciPharm Anterior/Posterior Composite Bonding Agent, Part A
Version/Model Number
SP 50-043
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
K791078
Product Code
EBD
Product Code Name
Coating, Filling Material, Resin
Public Device Record Key
7fb45e17-a213-42cc-a9b9-67f4059b0adf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 07, 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 |