FDUA 260-100-049

GUDID 00813110029010

FDUA Digital Abutment Analog Kit

BICON, LLC

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• Primary Device ID: 00813110029010
• NIH Device Record Key: f6e7ef33-a2a8-4cfe-83f7-937759c77dc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FDUA
• Version Model Number: 260-100-049
• Catalog Number: 260-100-049
• Company DUNS: 945015758
• Company Name: BICON, LLC
• 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: 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: 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
• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com
• Phone: 617-524-4443
• Email: support@bicon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813110029010 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-09
• Device Publish Date: 2021-09-01

Devices Manufactured by BICON, LLC

• 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
• 00813110029577 - Temporary Abutment: 2023-10-10 5.0 x 6.5mm Scannable Temporary Abutment - 3.0mm Tall Post
• 00813110029553 - Pliers: 2023-07-13 Diamond Pliers
• 00813110029560 - Tweezers: 2023-07-13 Titanium Tweezers