Dental Engineering Lab-TFRK

Basic Information

• Brand Name: Dental Engineering Lab-TFRK
• Primary DI: 00850001745086
• Version / Model: TFRK-L
• Catalog Number: TFRK-L
• Company Name: DENTAL ENGINEERING LABORATORIES, LLC
• Labeler DUNS: 026444360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-08
• Public Version: 1
• Public Version Date: 2018-11-08
• Public Version Status: New
• Public Device Record Key: c44c66f9-1ede-4da3-b689-868694bc7cfa

Device Description

Loop Device for Broken Endodontic File Removal

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63174	Endodontic file retrieval loop	A manually-operated dental instrument designed to retrieve a broken endodontic file from a root canal during endodontic dental surgery. It is a hand-held, thin metal shaft with a distal loop designed to lasso the file so that it can be pulled out from the root canal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850001745086	GS1

Customer Contacts

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