Duns Number:137217043
Device Description: Scott’s Select S-Bond is indicated for bonding to both enamel and dentin after acid etchin Scott’s Select S-Bond is indicated for bonding to both enamel and dentin after acid etching, in the restoration of teeth. Along with an etchant gel, it can provide a quick easy way to bond composite and restorations to the tooth. This bond provides both priming of and adhesion to enamel and dentin. Scott’s select S-bond is a methacrylate based monomer system and photosensitive catalyst in an acetone solvent. Instructions for use and SDS available at https://www.scottsdental.com/s-bond.html
Catalog Number
199-1017
Brand Name
Scott's Select S-Bond 5ml
Version/Model Number
199-1017
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
-
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
-
Product Code
KLE
Product Code Name
Agent, Tooth Bonding, Resin
Public Device Record Key
33f9ba77-84f3-4275-9e40-4afd9fe6aa6e
Public Version Date
August 26, 2020
Public Version Number
5
DI Record Publish Date
May 04, 2017
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 | 1050 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |