Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe

Basic Information

• Brand Name: Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe
• Primary DI: D83610111
• Version / Model: 1011
• Catalog Number: 1011
• Company Name: DENT ZAR, INC.
• Labeler DUNS: 789664455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-03
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5d75583b-1641-497f-ba33-591aa3b7233b

Device Description

Light Super Bond represents state-of- the-art technology: it offers the most desirable characteristics, in versatility, ease of handling and reliability. • Unlimited working time-cures on demand with a visible light-curing unit. • Bracket compatibility-designed to be used with ceramic, plastic or metal brackets. • Viscosity-consistency of the Light Super Bond-M paste eliminates bracket flotation. • High light sensitivity of the material allows for the use of Light Super Bond-M not only for bonding translucent (plastic or ceramic) brackets, but also for light impermeable metal ones. • Light Super Bond-M is a light cured material, which allows for relief from time pressure. • The dentist, therefore, has plenty of time for cleaning the excess adhesive around the bracket bases. • Simplicity of application procedure, and relief from time pressure, results in obtaining reproducible bond strength, and precise bracket placement. • The material has superior resistance to discoloration. It is economical to use and has virtually no waste and long shelf life, all of which contribute to the ease of working with this product.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	872.3750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. 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	D83610111	HIBCC