Fixed-Detachable Universal Abutment 260-302-725

GUDID 00813110028501

4mm FDUA TP 15° - 3.0mm Tall Post

BICON, LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00813110028501
• NIH Device Record Key: eef18cfd-0e4b-42db-b2d0-dcce6afa40a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixed-Detachable Universal Abutment
• Version Model Number: 260-302-725
• Catalog Number: 260-302-725
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813110028501 [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: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [Fixed-Detachable Universal Abutment]

• 00813110028501: 4mm FDUA TP 15° - 3.0mm Tall Post
• 00813110028495: 4mm FDUA TP 0° - 3.0mm Tall Post
• 00813110028488: 4mm FDUA SP 15° - 3.0mm Tall Post
• 00813110028471: 4mm FDUA SP 0° - 3.0mm Tall Post
• 00813110028464: 4mm FDUA TP 15° - 3.0mm Standard Post
• 00813110028457: 4mm FDUA TP 0° - 3.0mm Standard Post
• 00813110028440: 4mm FDUA SP 15° - 3.0mm Standard Post
• 00813110028433: 4mm FDUA SP 0° - 3.0mm Standard Post
• 00813110028426: 4mm FDUA TP 15° - 2.5mm Tall Post
• 00813110028419: 4mm FDUA TP 0° - 2.5mm Tall Post
• 00813110028402: 4mm FDUA SP 15° - 2.5mm Tall Post
• 00813110028396: 4mm FDUA SP 0° - 2.5mm Tall Post
• 00813110028389: 4mm FDUA TP 15° - 2.5mm Standard Post
• 00813110028372: 4mm FDUA TP 0° - 2.5mm Standard Post
• 00813110028365: 4mm FDUA SP 15° - 2.5mm Standard Post
• 00813110028358: 4mm FDUA SP 0° - 2.5mm Standard Post
• 00813110028341: 4mm FDUA TP 15° - 2.0mm Tall Post
• 00813110028334: 4mm FDUA TP 0° - 2.0mm Tall Post
• 00813110028327: 4mm FDUA SP 15° - 2.0mm Tall Post
• 00813110028310: 4mm FDUA SP 0° - 2.0mm Tall Post
• 00813110028303: 4mm FDUA TP 15° - 2.0mm Standard Post
• 00813110028297: 4mm FDUA TP 0° - 2.0mm Standard Post
• 00813110028280: 4mm FDUA SP 15° - 2.0mm Standard Post
• 00813110028273: 4mm FDUA SP 0° - 2.0mm Standard Post