Edge C-File

Basic Information

• Brand Name: Edge C-File
• Primary DI: 00810047644194
• Version / Model: CF1531
• Catalog Number: CF1531
• Company Name: US ENDODONTICS, LLC
• Labeler DUNS: 061317427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2023-04-25
• Public Version: 1
• Public Version Date: 2023-05-03
• Public Version Status: New
• Public Device Record Key: f6968b5f-311d-44b7-8093-d7179a989d25

Device Description

Endodontic Hand File

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKS	FILE, PULP CANAL, ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31863	Margin finishing dental file/rasp, reusable	A hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10810047644191	GS1
Primary	00810047644194	GS1

Customer Contacts

• Phone: [phone] ext. 103
• Email: [email protected]