L-SHA-Flowable Composite

Basic Information

• Brand Name: L-SHA-Flowable Composite
• Primary DI: D83610081
• Version / Model: 1008
• Catalog Number: 1008
• Company Name: DENT ZAR, INC.
• Labeler DUNS: 789664455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0cc2b69d-b180-470f-935a-16c905c05340

Device Description

L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.

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
EBF	Material, Tooth Shade, Resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be 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	D83610081	HIBCC