Console Optima MX2 INT 1600715-001

GUDID J00716007150011

iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).

Bien-Air Dental SA

Surgical power tool system control unit, line-powered

• Primary Device ID: J00716007150011
• NIH Device Record Key: 840a7e65-0ff2-4426-9492-8b78abf7fc19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Console Optima MX2 INT
• Version Model Number: 1600715-001
• Catalog Number: 1600715-001
• 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	J00716007150011 [Primary]

FDA Product Code

• EIA: Unit, operative dental

Sterilization

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

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

[J00716007150011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-25
• Device Publish Date: 2021-06-17

Devices Manufactured by Bien-Air Dental SA

• J00716011920011 - WIRELESS FOOTCTRL + DONGLE: 2025-02-28 Used to controle the console used in dentistry for implantology, dental surgery and endodontic work.
• J00717008890011 - Set Console CHIROPRO L US PREMIUM WL: 2025-02-28 Sets of Chiropro systems and their dental micromotors, contra-angles or handpieces, and releveant accessories
• J00716012350011 - CA PRIMA 1:1: 2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
• J00716012360011 - CA PRIMA 1:1 L: 2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
• J00716012370011 - CA PRIMA 1:1 L MS: 2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
• J00716012670011 - CA PRIMA 1:121: 2025-01-17 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
• J00716014080011 - PM CA 20:1 L RO 104936: 2024-12-06 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
• J00716014090011 - PM PM 1:1 RO sp. ext. 104936: 2024-12-06 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele