LUBRICARE MAINTENANCE SYSTEM

Basic Information

• Brand Name: LUBRICARE MAINTENANCE SYSTEM
• Primary DI: J00716009150011
• Version / Model: 1600915-001
• Catalog Number: 1600915-001
• Company Name: Bien-Air Dental SA
• Labeler DUNS: 480082080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-11
• Public Version: 2
• Public Version Date: 2021-06-24
• Public Version Status: Update
• Public Device Record Key: 2d9c6ab2-6fce-4367-a7a0-787f9da2a9a4

Device Description

Lubricare is intended for lubricating and cleaning the inside of dental instruments.

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
EFB	Handpiece, Air-Powered, Dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15772	Surgical instrument maintenance lubricant	A non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.	No	Active
44690	Dental handpiece maintenance unit	A device used for the automatic internal cleaning, lubrication and maintenance of dental handpieces used in dentistry (e.g., pneumatically or electrically driven scalers, motors, or turbines). This device will automatically run programs for, e.g., the cleaning and/or lubrication of the internal components with service oil, cleaning water/air spray channels with cleaning fluid and flushing with compressed air after external cleansing, but prior to sterilization. This process will improve performance and safety of the dental instruments. The unit is designed to accept different handpiece models, which are connected directly or via adaptors to the unit's processing chamber.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J00716009150011	HIBCC

Customer Contacts

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