G-aenial™

Basic Information

• Brand Name: G-aenial™
• Primary DI: 14548161327459
• Version / Model: 009174
• Catalog Number: 009174
• Company Name: Gc America Inc.
• Labeler DUNS: 005473608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-08-05
• Public Version: 1
• Public Version Date: 2022-08-15
• Public Version Status: New
• Public Device Record Key: 7b799ee3-49d3-4d1f-a535-e91eb9f9b623

Device Description

G-aenial™ Sculpt 20 Unitip B1 (0.16mL each)

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
Unit of Use	04548161327452	GS1
Primary	14548161327459	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123631	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 39 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius