Dental City

Basic Information

• Brand Name: Dental City
• Primary DI: D77139700
• Version / Model: 39-700
• Company Name: ICP, INC.
• Labeler DUNS: 808371371
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2021-07-19
• Public Version: 1
• Public Version Date: 2021-07-27
• Public Version Status: New
• Public Device Record Key: 896310cd-3fcc-4b10-b53f-fee96230d471

Device Description

K-Files 31mm #08

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
EKQ	Preparer, Root Canal Endodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63721	Endodontic enlarger, single-use	A non-sterile manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D771397000	HIBCC
Primary	D77139700	HIBCC