PEEK Temporary Abutment 260-150-745

GUDID 00813110027887

5.0 x 4.5mm PEEK Temporary Abutment - 2.0mm Post

BICON, LLC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00813110027887
• NIH Device Record Key: edc99a05-15f8-44f3-9adc-2e7bb5a2ff94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEEK Temporary Abutment
• Version Model Number: 260-150-745
• Catalog Number: 260-150-745
• 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	00813110027887 [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: 2
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-07-17

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• 00813110027894: 5.0 x 6.5mm PEEK Temporary Abutment - 2.0mm Post
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• 00813110027863: 4.0 x 4.5mm PEEK Temporary Abutment - 2.0mm Post