NA

Basic Information

• Brand Name: NA
• Primary DI: 00813110023452
• Version / Model: 260-028-425
• Catalog Number: 260-028-425
• Company Name: BICON, LLC
• Labeler DUNS: 945015758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-01
• Public Version: 4
• Public Version Date: 2020-03-24
• Public Version Status: Update
• Public Device Record Key: 40dc8c73-70ed-4cca-b9cd-26a4fb4a5ab4

Device Description

Motor for New Drill Unit

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45572	Dental power tool system, line-powered	An assembly of devices designed to both bore/excavate and saw bones, teeth, and tough tissues during a dental/maxillofacial surgical procedure. It typically consists of a motorized handpiece and/or motor, a control unit, and a variety of attachments used to hold the cutting instruments (e.g., drill bits, saw blades, burs, polishing disks). The system is electrically-powered from the mains (e.g., 230 or 115 volt) and supplies the handpiece/motor with low-voltage electricity (e.g., 24 volt) through the control unit. The system may operate through a dental delivery system or be freestanding and independent. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813110023452	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K111078	000