Fixation Implant

GUDID D824FRC35180

Ø3.5mm x L18.0mm, Conical Connection, Regular Platform

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824FRC35180
• NIH Device Record Key: 2433f676-fe34-454e-96d9-e8dc26b255b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixation Implant
• Version Model Number: FRC3518
• Company DUNS: 080321629
• Company Name: SURGIKOR, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D824FRC35180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152555

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: 2017-01-31

On-Brand Devices [Fixation Implant]

• D824FWC50180: Ø5.0mm x L18.0mm, Conical Connection, Wide Platform
• D824FWC50150: Ø5.0mm x L15.0mm, Conical Connection, Wide Platform
• D824FWC50130: Ø5.0mm x L13.0mm, Conical Connection, Wide Platform
• D824FWC50110: Ø5.0mm x L11.5mm, Conical Connection, Wide Platform
• D824FWC50100: Ø5.0mm x L10.0mm, Conical Connection, Wide Platform
• D824FWC50080: Ø5.0mm x L8.5 mm, Conical Connection, Wide Platform
• D824FWC43180: Ø4.3mm x L18.0mm, Conical Connection, Wide Platform
• D824FWC43150: Ø4.3mm x L15.0mm, Conical Connection, Wide Platform
• D824FWC43130: Ø4.3mm x L13.0mm, Conical Connection, Wide Platform
• D824FWC43110: Ø4.3mm x L11.5mm, Conical Connection, Wide Platform
• D824FWC43100: Ø4.3mm x L10.0mm, Conical Connection, Wide Platform
• D824FWC43080: Ø4.3mm x L 8.5mm, Conical Connection, Wide Platform
• D824FRC35180: Ø3.5mm x L18.0mm, Conical Connection, Regular Platform
• D824FRC35150: Ø3.5mm x L15.0mm, Conical Connection, Regular Platform
• D824FRC35130: Ø3.5mm x L13.0mm, Conical Connection, Regular Platform
• D824FRC35110: Ø3.5mm x L11.5mm, Conical Connection, Regular Platform
• D824FRC35100: Ø3.5mm x L10.0mm, Conical Connection, Regular Platform
• D824FRC35080: Ø3.5mm x L8.5mm, Conical Connection, Regular Platform
• D824FNC30150: Ø3.0mm x L15.0mm, Conical Connection, Narrow Platform
• D824FNC30130: Ø3.0mm x L13.0mm, Conical Connection, Narrow Platform
• D824FNC30110: Ø3.0mm x L11.5mm, Conical Connection, Narrow Platform
• D824FNC30100: Ø3.0mm x L10mm, Conical Connection, Narrow Platform
• D824FRC39180: Ø3.9mm x L18.0mm, Conical Connection, Regular Platform
• D824FRC39150: Ø3.9mm x L15.0mm, Conical Connection, Regular Platform
• D824FRC39130: Ø3.9mm x L13.0mm, Conical Connection, Regular Platform
• D824FRC39110: Ø3.9mm x L11.5mm, Conical Connection, Regular Platform
• D824FRC39100: Ø3.9mm x L10.0mm, Conical Connection, Regular Platform
• D824FRC39080: Ø3.9mm x L8.5mm, Conical Connection, Regular Platform