HyFlex CM

Basic Information

• Brand Name: HyFlex CM
• Primary DI: D661SBHGPF825ASST1
• Version / Model: SBHGPF825ASST
• Company Name: COLTENE/WHALEDENT INC
• Labeler DUNS: 622185718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2023-06-22
• Public Version: 1
• Public Version Date: 2023-06-30
• Public Version Status: New
• Public Device Record Key: 011bd45d-767c-4fad-b03e-ed9678755408

Device Description

GLIDEPATH FILE ASST 25 MM

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
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
Unit of Use	D661SBHGPF825ASST0	HIBCC
Primary	D661SBHGPF825ASST1	HIBCC

Customer Contacts

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