PM 1:1 TWIST DRILL 1601190-001

GUDID J00716011900011

Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor. Product intended for use in oral and maxillofacial surgery.

Bien-Air Dental SA

Dental laboratory drilling system handpiece

• Primary Device ID: J00716011900011
• NIH Device Record Key: 88f55f38-337a-44e9-9c24-afa1d58e69cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PM 1:1 TWIST DRILL
• Version Model Number: 1601190-001
• Catalog Number: 1601190-001
• 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: 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
• 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	J00716011900011 [Primary]

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental
• GFA: Blade, Saw, General & Plastic Surgery, Surgical

Sterilization

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

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

[J00716011900011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-20
• Device Publish Date: 2022-07-12

Devices Manufactured by Bien-Air Dental SA

• 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
• 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.