Non-Shouldered Straight Abutment

GUDID D824NS15RH0

Ø3.75mm x L15.0mm, Hex Connection, Regular Platform

SURGIKOR, LLC

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

• Primary Device ID: D824NS15RH0
• NIH Device Record Key: 2a86aae0-c945-453c-bf33-3181a31b576f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Shouldered Straight Abutment
• Version Model Number: NS15RH
• 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: false
• 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	D824NS15RH0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152555

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D824NS15RH0]

Moist Heat or Steam Sterilization

[D824NS15RH0]

Moist Heat or Steam Sterilization

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 [Non-Shouldered Straight Abutment]

• D824NSN9NC0: Ø3.0mm x L9.0mm, Narrow Emergence, Conical Connection, Narrow Platform
• D824NSN7NC0: Ø3.0mm x L7.0mm, Narrow Emergence, Conical Connection, Narrow Platform
• D824NSN5NC0: Ø3.0mm x L5.0mm, Narrow Emergence, Conical Connection, Narrow Platform
• D824NS9WC0: Ø4.3mm x L9.0mm, Conical Connection, Wide Platform
• D824NS9RH0: Ø3.75mm x L9.0mm, Hex Connection, Regular Platform
• D824NS9RC0: Ø3.5mm x L9.0mm, Conical Connection, Regular Platform
• D824NS9NC0: Ø3.0mm x L9.0mm, Conical Connection, Narrow Platform
• D824NS7WC0: Ø4.3mm x L7.0mm, Conical Connection, Wide Platform
• D824NS7RH0: Ø3.75mm x L7.0mm, Hex Connection, Regular Platform
• D824NS7RC0: Ø3.5mm x L7.0mm, Conical Connection, Regular Platform
• D824NS7NC0: Ø3.0mm x L7.0mm, Conical Connection, Narrow Platform
• D824NS5WC0: Ø4.3mm x L5.0mm, Conical Connection, Wide Platform
• D824NS5RH0: Ø3.75mm x L5.0mm, Hex Connection, Regular Platform
• D824NS5RC0: Ø3.5mm x L5.0mm, Conical Connection, Regular Platform
• D824NS5NC0: Ø3.0mm x L5.0mm, Conical Connection, Narrow Platform
• D824NS15WC0: Ø4.3mm x L15.0mm, Conical Connection, Wide Platform
• D824NS15RH0: Ø3.75mm x L15.0mm, Hex Connection, Regular Platform
• D824NS15RC0: Ø3.5mm x L15.0mm, Conical Connection, Regular Platform
• D824NS15NC0: Ø3.0mm x L15.0mm, Conical Connection, Narrow Platform
• D824NS12WC0: Ø4.3mm x L12.0mm, Conical Connection, Wide Platform
• D824NS12RH0: Ø3.75mm x L12.0mm, Hex Connection, Regular Platform
• D824NS12RC0: Ø3.5mm x L12.0mm, Conical Connection, Regular Platform
• D824NS12NC0: Ø3.0mm x L12.0mm, Conical Connection, Narrow Platform