Implant 260-425-108

GUDID 00813110023346

2.5 x 8.0 x 4.0mm 0° Stealth Transitional Implant

BICON, LLC

Basket endosteal dental implant, one-piece

• Primary Device ID: 00813110023346
• NIH Device Record Key: ee8a5770-19ac-497b-a4a1-bc13f49fe732
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant
• Version Model Number: 260-425-108
• Catalog Number: 260-425-108
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813110023346 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-06

On-Brand Devices [Implant]

• 00813110023377: 2.5 x 10mm Orthodontic Implant
• 00813110023353: 2.5 x 12 x 4.0mm 0° Stealth Transitional Implant
• 00813110023346: 2.5 x 8.0 x 4.0mm 0° Stealth Transitional Implant
• 00813110028594: 4.0 x 8.0mm TP 0° FDUA Transitional Implant
• 00813110028587: 4.0 x 8.0mm SP 0° FDUA Transitional Implant
• 00813110028570: 4.0 x 6.0mm TP 0° FDUA Transitional Implant
• 00813110028563: 4.0 x 6.0mm SP 0° FDUA Transitional Implant
• 00813110029294: 4.0 x 10mm TP 0° FDUA Transitional Implant
• 00813110029287: 4.0 x 10mm SP 0° FDUA Transitional Implant