260-028-425

GUDID 00813110023452

Motor for New Drill Unit

BICON, LLC

Dental power tool system, line-powered Dental power tool system, line-powered

• Primary Device ID: 00813110023452
• NIH Device Record Key: 40dc8c73-70ed-4cca-b9cd-26a4fb4a5ab4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 260-028-425
• Catalog Number: 260-028-425
• 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	00813110023452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111078

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• 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