Overdenture 260-300-505

GUDID 00813110029270

5.0mm Overdenture Abutment - 3.0mm Post

BICON, LLC

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• Primary Device ID: 00813110029270
• NIH Device Record Key: adfd2184-e211-4b57-86bc-380051dc399f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Overdenture
• Version Model Number: 260-300-505
• Catalog Number: 260-300-505
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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	00813110029270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K853788

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2021-11-04
• Device Publish Date: 2021-10-27

On-Brand Devices [Overdenture]

• 00813110029270: 5.0mm Overdenture Abutment - 3.0mm Post
• 00813110029263: 4.0mm Overdenture Abutment - 3.0mm Post
• 00813110029256: 3.0mm Overdenture Abutment - 3.0mm Post
• 00813110029249: 1.0mm Overdenture Abutment - 3.0mm Post
• 00813110029232: 2.0mm Overdenture Abutment - 3.0mm Post
• 00813110029225: 5.0mm Overdenture Abutment - 2.5mm Post
• 00813110029218: 4.0mm Overdenture Abutment - 2.5mm Post
• 00813110029201: 3.0mm Overdenture Abutment - 2.5mm Post
• 00813110029195: 2.0mm Overdenture Abutment - 2.5mm Post
• 00813110029188: 1.0mm Overdenture Abutment - 2.5mm Post
• 00813110029171: 5.0mm Overdenture Abutment - 2.0mm Post
• 00813110029164: 4.0mm Overdenture Abutment - 2.0mm Post
• 00813110029157: 3.0mm Overdenture Abutment - 2.0mm Post
• 00813110029140: 2.0mm Overdenture Abutment - 2.0mm Post
• 00813110029133: 1.0mm Overdenture Abutment - 2.0mm Post