Lubricare Maintenance System 1600915-001

GUDID J0071600915011

Device used to maintain optimum performance and prolong working life of dental handpieces. Delivers oli and air automatically to the handpiece and is used after dental treatement before autoclaving

Bien-Air Dental SA

Dental handpiece maintenance unit

• Primary Device ID: J0071600915011
• NIH Device Record Key: 79865eb6-ee15-48ae-8045-e0cafc3c2daf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lubricare Maintenance System
• Version Model Number: 1600915-001
• Catalog Number: 1600915-001
• Company DUNS: 480082080
• Company Name: Bien-Air Dental SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J0071600915011 [Primary]

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-01
• Device Publish Date: 2021-06-23

On-Brand Devices [Lubricare Maintenance System]

• J00716009150011: Lubricare is intended for lubricating and cleaning the inside of dental instruments.
• J0071600915011: Device used to maintain optimum performance and prolong working life of dental handpieces. Deliv