Integra-CP 260-335-011

GUDID 00813110022516

3.5 x 11mm Integra-CP Implant - 2.0mm Well

BICON, LLC

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

• Primary Device ID: 00813110022516
• NIH Device Record Key: 4443534b-dd6e-4e18-9d98-7d960e4d0375
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra-CP
• Version Model Number: 260-335-011
• Catalog Number: 260-335-011
• 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	00813110022516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921805

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-07

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• 00813110023056: 6.0 x 5.0mm Integra-CP Implant - 3.0mm Well
• 00813110023049: 6.0 x 8.0mm Integra-CP Implant - 3.0mm Well
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• 00813110022684: 4.5 x 6.0mm Integra-CP Implant - 3.0mm Well
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• 00813110022660: 4.5 x 6.0mm Integra-CP Implant - 2.5mm Well
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• 00813110022615: 4.0 x 8.0mm Integra-CP Implant - 2.5mm Well
• 00813110022608: 4.0 x 6.0mm Integra-CP Implant - 2.5mm Well
• 00813110022592: 4.0 x 5.0mm Integra-CP Implant - 2.5mm Well
• 00813110022585: 4.0 x 11mm Integra-CP Implant - 2.5mm Well
• 00813110022547: 4.0 x 11mm Integra-CP Implant - 2.0mm Well
• 00813110022530: 4.0 x 8.0mm Integra-CP Implant - 2.0mm Well
• 00813110022516: 3.5 x 11mm Integra-CP Implant - 2.0mm Well
• 00813110022509: 3.5 x 8.0mm Integra-CP Implant - 2.0mm Well
• 00813110022493: 3.0 x 8.0mm Integra-CP Implant - 2.0mm Well
• 00813110022486: 3.0 x 6.0mm Integra-CP Implant - 2.0mm Well
• 00813110029126: 4.0 x 5.0mm Integra-CP Implant - 2.0mm Well