Scott's Select Plus SE Bond Unit Dose - SELF-ETCH (SE) BONDING AGENT is indicated for the - SCOTT'S DENTAL SUPPLY L.L.C.

Duns Number:137217043

Device Description: SELF-ETCH (SE) BONDING AGENT is indicated for the bonding of direct composite, resin modif SELF-ETCH (SE) BONDING AGENT is indicated for the bonding of direct composite, resin modified glass ionomers or compomers to dentin/enamel. SE BONDING AGENT is a self-etch, light-cure one component adhesive resin system designed to bond composites to enamel and dentin. It is a quick and easy way to bond composites to the tooth. SE BONDING AGENT provides "all in one": etching of, priming of and adhesion to enamel and dentin. This system is responsive to any dental curing light; the curing times can vary with the radiance of the light source. SE Bonding Agent is a dimethacrylate based bonding system with photosensitizers. This kit contains 50 unit dose tips and 50 applicator brushes. Instructions for use and SDS available at https://www.scottsdental.com/select-plus-bond.html

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More Product Details

Catalog Number

199-1057

Brand Name

Scott's Select Plus SE Bond Unit Dose

Version/Model Number

199-1057

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

565171ea-fb62-41cc-a545-7476098d1ce4

Public Version Date

August 26, 2020

Public Version Number

5

DI Record Publish Date

March 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCOTT'S DENTAL SUPPLY L.L.C." Characteristics
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