NGO motor driver

GUDID J00715031850011

NGO motor driver 1503185-001 Update of the motor control board of the console OPTIMA MX: Added a switch motor on top of the motor board that can control up to 3 motors.

Bien-Air Dental SA

Dental surgical power tool motor, electric

• Primary Device ID: J00715031850011
• NIH Device Record Key: 45c81274-c019-4c4e-b5ce-a3936ab52ce6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NGO motor driver
• Version Model Number: 1503185-001
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00715031850011 [Primary]

FDA Product Code

• IFP: Formalin, Neutral Buffered

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: 2023-09-25
• Device Publish Date: 2023-09-15

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