Bien Air 81408

GUDID J007BA814080

Bien Air RA Bone Cutter 161-016 - STERILE

Ss White Burs, Inc.

Carbide dental bur, reusable

• Primary Device ID: J007BA814080
• NIH Device Record Key: 78295793-3f9d-402c-ae7a-7dce90fb8a25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bien Air
• Version Model Number: BA81408
• Catalog Number: 81408
• Company DUNS: 151760014
• Company Name: Ss White Burs, Inc.
• Device Count: 5
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com
• Phone: +1(732)905-1100
• Email: customerservice@sswhitedental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J007BA814080 [Unit of Use]
HIBCC	J007BA814081 [Primary]

FDA Product Code

• EJL: BUR, DENTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-04
• Device Publish Date: 2025-02-24

On-Brand Devices [Bien Air]

• J007BA814150: Bien Air RA Diamond 856-016 Medium - STERILE
• J007BA814140: Bien Air RA Surgical Carbide #703 - STERILE
• J007BA814130: Bien Air RA Surgical Carbide #702 - STERILE
• J007BA814120: Bien Air RA Surgical Carbide #8 - STERILE
• J007BA814110: Bien Air RA Surgical Carbide #6 - STERILE
• J007BA814100: Bien Air RA Surgical Carbide #4 - STERILE
• J007BA814090: Bien Air RA Surgical Carbide #2 - STERILE
• J007BA814080: Bien Air RA Bone Cutter 161-016 - STERILE
• J007BA814070: Bien Air RA Diamond 856-016 Medium
• J007BA814060: Bien Air RA Surgical Carbide #703
• J007BA814050: Bien Air RA Surgical Carbide #702
• J007BA814040: Bien Air RA Surgical Carbide #8
• J007BA814030: Bien Air RA Surgical Carbide #6
• J007BA814020: Bien Air RA Surgical Carbide #4
• J007BA814010: Bien Air RA Surgical Carbide #2
• J007BA814000: Bien Air RA Bone Cutter 161-016