NANOHYBRID COMPULES 15-.3 Gm (C1)

Basic Information

• Brand Name: NANOHYBRID COMPULES 15-.3 Gm (C1)
• Primary DI: D77819940081
• Version / Model: 199-4008
• Catalog Number: 199-4008
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2017-05-04
• Public Version: 4
• Public Version Date: 2020-08-26
• Public Version Status: Update
• Public Device Record Key: bf8154ed-bfec-4717-b3f5-be3099a437b9

Device Description

Nanohybrid Composite contains a new ytterbium fluoride mono-dispersed nano-sized particle which combined with regular silica and barium glass composes a state of the art nano-filler system. Nanohybrid Composite is a high viscosity composite that will resist sticking to instruments, yet will have sufficient flow to adapt to the walls of the cavity preparation. Nanohybrid Composite is radio-opaque and provides high compressive and flexural strengths along with a low water uptake. Nanohybrid Composite meets the ISO 4049 standard (Type 1, Class 2). Delivery method is .3 Gm unit dose compules. Color/Shade: C1. SDS and Instructions for use available at: https://www.scottsdental.com/nanohybrid-composite-compules-scott-s-select.html

Device Characteristics

• Single Use: Yes
• 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
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	D77819940081	HIBCC
Unit of Use	D77819940080	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	.3	Gram

Storage Conditions

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