C-Root

Basic Information

• Brand Name: C-Root
• Primary DI: 06972902588112
• Version / Model: 015/08 19mm
• Catalog Number: file 015/08 19mm
• Company Name: Beijing C-Root Dental Medical Devices Co., LTD.
• Labeler DUNS: 415018580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-08
• Public Version: 1
• Public Version Date: 2025-06-16
• Public Version Status: New
• Public Device Record Key: dbbf7811-9a27-486d-8776-3d73c44c2497

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
63550	Rotary/reciprocating endodontic file/rasp, single-use	A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06972902588112	GS1
Package	16972902588119	GS1	box	10	In Commercial Distribution
Package	26972902588116	GS1	carton	75	In Commercial Distribution