Duns Number:096010525
Device Description: Universal Copal Cavity Varnish was formulated to protect dentin from acids released by fil Universal Copal Cavity Varnish was formulated to protect dentin from acids released by filling materials. Provides a chemical and thermal barrier while eliminating air pockets. Trial Size. Boxed.
Catalog Number
71-03
Brand Name
SciPharm Copal Cavity Varnish
Version/Model Number
SP 71-03
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
K800438
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
8d4f2eb6-b89c-4dcd-bd73-34a061ab5517
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 11, 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 |