Non-Shouldered Straight Abutment - Wide Emergence

GUDID D824NSW12RH0

Ø3.75mm x L12.0mm, Wide Emergence, Hex Connection, Regular Platform

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824NSW12RH0
• NIH Device Record Key: b3dc972a-2b54-40f2-aba9-0c1846d48649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Shouldered Straight Abutment - Wide Emergence
• Version Model Number: NSW12RH
• 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	D824NSW12RH0 [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

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

Moist Heat or Steam Sterilization

[D824NSW12RH0]

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 - Wide Emergence]

• D824NSW9WC0: Ø4.3mm x L9.0mm, Wide Emergence, Conical Connection, Wide Platform
• D824NSW9RH0: Ø3.75mm x L9.0mm, Wide Emergence, Hex Connection, Regular Platform
• D824NSW9RC0: Ø3.5mm x L9.0mm, Wide Emergence, Conical Connection, Regular Platform
• D824NSW9NC0: Ø3.0mm x L9.0mm, Wide Emergence, Conical Connection, Narrow Platform
• D824NSW12WC0: Ø4.3mm x L12.0mm, Wide Emergence, Conical Connection, Wide Platform
• D824NSW12RH0: Ø3.75mm x L12.0mm, Wide Emergence, Hex Connection, Regular Platform
• D824NSW12RC0: Ø3.5mm x L12.0mm, Wide Emergence, Conical Connection, Regular Platform
• D824NSW12NC0: Ø3.0mm x L12.0mm, Wide Emergence, Conical Connection, Narrow Platform