Integra-Ti 260-140-005

GUDID 00813110029119

4.0 x 5.0mm Integra-Ti Implant - 2.0mm Well

BICON, LLC

Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece Basket endosteal dental implant, two-piece

• Primary Device ID: 00813110029119
• NIH Device Record Key: e441d915-1929-4d5b-b71b-9bb14063d367
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra-Ti
• Version Model Number: 260-140-005
• Catalog Number: 260-140-005
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813110029119 [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: 2022-01-18
• Device Publish Date: 2022-01-10

On-Brand Devices [Integra-Ti]

• 00813110027856: 4.5 x 5.0mm Integra-Ti Implant - 3.0mm Well
• 00813110027429: 3.0 x 6.0mm Integra-Ti Implant - 2.0mm Well
• 00813110021212: 6.0 x 5.7mm Integra-Ti Implant - 3.0mm Well
• 00813110021205: 6.0 x 6.0mm Integra-Ti Implant - 3.0mm Well
• 00813110021199: 6.0 x 5.0mm Integra-Ti Implant - 3.0mm Well
• 00813110021083: 5.0 x 11mm Integra-Ti Implant - 3.0mm Well
• 00813110021076: 5.0 x 8.0mm Integra-Ti Implant - 3.0mm Well
• 00813110021069: 5.0 x 6.0mm Integra-Ti Implant - 3.0mm Well
• 00813110021052: 5.0 x 5.0mm Integra-Ti Implant - 3.0mm Well
• 00813110020956: 4.5 x 11mm Integra-Ti Implant - 3.0mm Well
• 00813110020949: 4.5 x 8.0mm Integra-Ti Implant - 3.0mm Well
• 00813110020932: 4.5 x 6.0mm Integra-Ti Implant - 3.0mm Well
• 00813110020925: 4.5 x 8.0mm Integra-Ti Implant - 2.5mm Well
• 00813110020918: 4.5 x 6.0mm Integra-Ti Implant - 2.5mm Well
• 00813110020901: 4.5 x 5.0mm Integra-Ti Implant - 2.5mm Well
• 00813110020895: 4.5 x 11mm Integra-Ti Implant - 2.5mm Well
• 00813110020819: 4.0 x 8.0mm Integra-Ti Implant - 2.5mm Well
• 00813110020802: 4.0 x 6.0mm Integra-Ti Implant - 2.5mm Well
• 00813110020796: 4.0 x 5.0mm Integra-Ti Implant - 2.5mm Well
• 00813110020789: 4.0 x 11mm Integra-Ti Implant - 2.5mm Well
• 00813110020727: 4.0 x 11mm Integra-Ti Implant - 2.0mm Well
• 00813110020710: 4.0 x 8.0mm Integra-Ti Implant - 2.0mm Well
• 00813110020666: 3.5 x 11mm Integra-Ti Implant - 2.0mm Well
• 00813110020659: 3.5 x 8.0mm Integra-Ti Implant - 2.0mm Well
• 00813110020635: 3.0 x 8.0mm Integra-Ti Implant - 2.0mm Well
• 00813110029119: 4.0 x 5.0mm Integra-Ti Implant - 2.0mm Well