Nuance®

Basic Information

• Brand Name: Nuance®
• Primary DI: D813CR11040
• Version / Model: CR1104
• Catalog Number: CR1104
• Company Name: DEN-MAT HOLDINGS, LLC
• Labeler DUNS: 809857704
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d4e96532-5b17-4755-a4bb-c3356bce31a7

Device Description

NUANCE A3.5 UNIVERSAL SYR

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
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	D813CR11040	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101215	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 36 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 36 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Nuance FLOW should not be used past the expiration date listed on the syringe.
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight, extreme heat or open flame.
• Type: Special Storage Condition, Specify
• Special Conditions: After extrusion, securely place the cap onto the syringe. This will protect Nuance from ambient light, as well as foreign objects.