260-028-201

GUDID 00813110023421

20:1 Contra Angle Handpiece (high torque)

BICON, LLC

Dental power tool system handpiece, remotely-driven Dental power tool system handpiece, remotely-driven

• Primary Device ID: 00813110023421
• NIH Device Record Key: 453d8f57-9ce7-41d2-8db6-411d31a9aad2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 260-028-201
• Catalog Number: 260-028-201
• Company DUNS: 945015758
• Company Name: BICON, LLC
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813110023421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011061

FDA Product Code

• EGS: Handpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

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

[00813110023421]

Moist Heat or Steam Sterilization

[00813110023421]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-24
• Device Publish Date: 2016-11-01

Devices Manufactured by BICON, LLC

• 00813110029638 - Universal Abutment: 2024-07-17 Universal Abutment UA4 SP 0° - 2.5mm Tall Post
• 00813110029645 - Universal Abutment: 2024-07-17 Universal Abutment UA4 SP 15° - 2.5mm Tall Post
• 00813110029652 - Milling Blank: 2024-07-16 10mm UA4 Milling Blank - 2.5mm Tall Post
• 00813110029607 - Temporary Abutment: 2024-07-04 4.0 x 2.5mm Scannable Temporary Abutment - 2.5mm Tall Post
• 00813110029614 - Temporary Abutment: 2024-07-04 4.0 x 4.5mm Scannable Temporary Abutment - 2.5mm Tall Post
• 00813110029621 - Temporary Abutment: 2024-07-04 4.0 x 6.5mm Scannable Temporary Abutment - 2.5mm Tall Post
• 00813110029591 - Temporary Abutment: 2024-05-14 5.0 x 6.5mm Scannable Temporary Abutment - 2.5mm Tall Post
• 00813110029485 - Temporary Abutment: 2024-01-23 7.0mm Thin Crestal Temporary Abutment - 3.0mm Tall Post