Scott's Select S-Bond 5ml

Basic Information

• Brand Name: Scott's Select S-Bond 5ml
• Primary DI: D77819910170
• Version / Model: 199-1017
• Catalog Number: 199-1017
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-04
• Public Version: 6
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 33f9ba77-84f3-4275-9e40-4afd9fe6aa6e

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLE	Agent, Tooth Bonding, Resin	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D77819910170	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	5	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius