iOptima APP 1400063

GUDID J00714000630631

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

Dental treatment application software

• Primary Device ID: J00714000630631
• NIH Device Record Key: c2c96058-8fc3-4436-a1d8-df7221bc8d1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iOptima APP
• Version Model Number: 1400063
• Catalog Number: 1400063
• Company DUNS: 480082080
• Company Name: Bien-Air Dental SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	J00714000630631 [Primary]

FDA Product Code

• OUG: Medical Device Data System

Sterilization

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

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

[J00714000630631]

Moist Heat or Steam Sterilization

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

Devices Manufactured by Bien-Air Dental SA

• J00716012420011 - XPU MMOTOR LIGHT: 2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
• J00716012450011 - I-SURGER LED: 2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
• J00716012470011 - LIGHT MOTOR: 2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
• J00717008000011 - SET STUDENTS BAUSA 8: 2024-01-31 SET of different CA & HP supplied for students.
• J00717008170011 - SET OPTIMA MX2 EDUCATIONAL 6: 2024-01-31 Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit.
• J00717008420011 - SET STUDENTS BAUSA 13: 2024-01-31 SET of different CA & HP supplied for students.
• J00717008570011 - SET STUDENTS BAUSA 14: 2024-01-31 SET of different CA & HP supplied for students.
• J007160005201 - PM HP 1:1 sp. ext.: 2023-12-21 CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain