Duns Number:096010525
Device Description: Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched Enamel. White Opaque Kit.
Catalog Number
56-01
Brand Name
SciPharm Pit & Fissure Sealer Bonding Agent
Version/Model Number
SP 56-01
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
K813091
Product Code
EBC
Product Code Name
Sealant, Pit And Fissure, And Conditioner
Public Device Record Key
08b83ff4-b342-4e4b-b3a6-153631159bf0
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 |