Edge One R GP

Basic Information

• Brand Name: Edge One R GP
• Primary DI: 08800069209763
• Version / Model: EORGPAST-1
• Company Name: SURE DENT CORPORATION
• Labeler DUNS: 688273010
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2023-08-16
• Public Version: 1
• Public Version Date: 2023-08-24
• Public Version Status: New
• Public Device Record Key: a7d8c94f-e611-4863-9bc5-2af36b704730

Device Description

EDGE ONE R GUTTA PERCHA ASSORTED - (20,25,35,40,45,50)

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: Yes
• 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
EKM	Gutta-Percha	Dental	872.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45081	Synthetic gutta-percha	A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. 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	88800069209769	GS1
Primary	08800069209763	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature away from direct sunlight