Fixation One

GUDID D824FRC43110

Ø4.3mm x L11.5mm, Conical Connection, Regular Platform

Surgikor, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824FRC43110
• NIH Device Record Key: 39cc0b1e-857b-494d-b1b8-36971094f977
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixation One
• Version Model Number: FRC4311
• 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	D824FRC43110 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-23
• Device Publish Date: 2025-12-15

On-Brand Devices [Fixation One]

• D824FRC50180: Ø5.0mm x L18.0mm, Conical Connection, Regular Platform
• D824FRC50150: Ø5.0mm x L15.0mm, Conical Connection, Regular Platform
• D824FRC50130: Ø5.0mm x L13.0mm, Conical Connection, Regular Platform
• D824FRC50110: Ø5.0mm x L11.5mm, Conical Connection, Regular Platform
• D824FRC50100: Ø5.0mm x L10.0mm, Conical Connection, Regular Platform
• D824FRC50080: Ø5.0mm x L8.5mm, Conical Connection, Regular Platform
• D824FRC43180: Ø4.3mm x L18.0mm, Conical Connection, Regular Platform
• D824FRC43150: Ø4.3mm x L15.0mm, Conical Connection, Regular Platform
• D824FRC43130: Ø4.3mm x L13.0mm, Conical Connection, Regular Platform
• D824FRC43110: Ø4.3mm x L11.5mm, Conical Connection, Regular Platform
• D824FRC43100: Ø4.3mm x L10.0mm, Conical Connection, Regular Platform