Scott's Select Plus SE Bond Unit Dose

Primary DI
D77819910571
Brand
Scott's Select Plus SE Bond Unit Dose
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
199-1057
Catalog number
199-1057
Device description
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 BONDIG 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
Published
2017-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KLEAgent, Tooth Bonding, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
KLEAgent, Tooth Bonding, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77819910571PrimaryHIBCC0

GMDN Terms

TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Total Volume0.125Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
137217043
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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