MC3 LK + 4VR400

Basic Information

• Brand Name: MC3 LK + 4VR400
• Primary DI: J00717000460011
• Version / Model: 1700046-001
• Catalog Number: 1700046-001
• 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: 2
• Public Version Date: 2021-06-30
• Public Version Status: Update
• Public Device Record Key: c1b6b23b-fbca-422a-9de9-aef0b1264c53

Device Description

Set of micromotor and Accessory connects micro-motors to the console

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: 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
EFB	Handpiece, air-powered, dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38763	Remotely-driven dental drilling system motor	A mains electricity (AC-powered) compact motor used in conjunction with a spinning cable (e.g., a Bowden cable) to provide remote rotational power from the motor to a dental drill handpiece. This device is line-powered and cannot be sterilized. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J00717000460011	HIBCC

Customer Contacts

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