Duns Number:096010525
Device Description: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restor Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Boxed.
Catalog Number
75-031
Brand Name
SciPharm Fluoroseal Cavity Liner
Version/Model Number
SP 75-031 B
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
K860633
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
c5965461-64ca-4adb-83d3-759a07e0b223
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 |