FOOTCTRL CHIROPRO980

Basic Information

• Brand Name: FOOTCTRL CHIROPRO980
• Primary DI: J00716002810011
• Version / Model: 1600281-001
• Catalog Number: 1600281-001
• Company Name: Bien-Air Dental SA
• Labeler DUNS: 480082080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-17
• Public Version: 1
• Public Version Date: 2021-06-25
• Public Version Status: New
• Public Device Record Key: f3952d4d-18fe-4d0e-9a93-ad8fb7b7a90b

Device Description

Used to control the console used in dentistry for implantology, dental surgery and endodontic work.

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: Yes
• Has Lot/Batch Number: No
• 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
EBW	Controller, foot, handpiece and cord	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36336	Foot-switch, electrical	An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J00716002810011	HIBCC

Customer Contacts

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