DIA-X FILE

Basic Information

• Brand Name: DIA-X FILE
• Primary DI: 08806383556927
• Version / Model: 25mm D1
• Catalog Number: 571-201
• Company Name: DiaDent Group International
• Labeler DUNS: 687789453
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-27
• Public Version: 1
• Public Version Date: 2020-06-04
• Public Version Status: New
• Public Device Record Key: 6fb5d97b-65eb-477b-8748-3617f77d19ef

Device Description

Dia-X File is for use in endodontic treatment.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
DZA	Drill, Dental, Intraoral	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40529	Rotary/reciprocating endodontic file/rasp, reusable	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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806383556927	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry