CA 1:2.5 L MS 1601164-001

GUDID J00716011640011

CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed

Bien-Air Dental SA

Dental laboratory drilling system handpiece

• Primary Device ID: J00716011640011
• NIH Device Record Key: 1dc03bfa-2e51-43ed-87d7-b805d7286f46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CA 1:2.5 L MS
• Version Model Number: 1601164-001
• Catalog Number: 1601164-001
• 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	J00716011640011 [Primary]

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

[J00716011640011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-25
• Device Publish Date: 2023-07-17

On-Brand Devices [CA 1:2.5 L MS]

• J00716010550011: CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or e
• J00716011640011: CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or e