Temporary Abutment

GUDID D824TAB5RH0

Ø3.75mm x L5.0mm, Hex Connection, Regular Platform

SURGIKOR, LLC

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

• Primary Device ID: D824TAB5RH0
• NIH Device Record Key: 961034ef-aef1-4f1f-ade1-eb255575784b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Temporary Abutment
• Version Model Number: TAB5RH
• 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	D824TAB5RH0 [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

[D824TAB5RH0]

Moist Heat or Steam Sterilization

[D824TAB5RH0]

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 [Temporary Abutment]

• D824TAB7WC0: Ø4.3mm x L7.0mm, Conical Connection, Wide Platform
• D824TAB7RH0: Ø3.75mm x L7.0mm, Hex Connection, Regular Platform
• D824TAB7RC0: Ø3.5mm x L7.0mm, Conical Connection, Regular Platform
• D824TAB7NC0: Ø3.0mm x L7.0mm, Conical Connection, Narrow Platform
• D824TAB6WC0: Ø4.3mm x L6.0mm, Conical Connection, Wide Platform
• D824TAB6RH0: Ø3.75mm x L6.0mm, Hex Connection, Regular Platform
• D824TAB6RC0: Ø3.5mm x L6.0mm, Conical Connection, Regular Platform
• D824TAB6NC0: Ø3.0mm x L6.0mm, Conical Connection, Narrow Platform
• D824TAB5WC0: Ø4.3mm x L5.0mm, Conical Connection, Wide Platform
• D824TAB5RH0: Ø3.75mm x L5.0mm, Hex Connection, Regular Platform
• D824TAB5RC0: Ø3.5mm x L5.0mm, Conical Connection, Regular Platform
• D824TAB5NC0: Ø3.0mm x L5.0mm, Conical Connection, Narrow Platform
• D824TAB4WC0: Ø4.3mm x L4.0mm, Conical Connection, Wide Platform
• D824TAB4RH0: Ø3.75mm x L4.0mm, Hex Connection, Regular Platform
• D824TAB4RC0: Ø3.5mm x L4.0mm, Conical Connection, Regular Platform
• D824TAB4NC0: TAB4NC
• D824TAB3WC0: Ø4.3mm x L3.0mm, Conical Connection, Wide Platform
• D824TAB3RH0: Ø3.75mm x L3.0mm, Hex Connection, Regular Platform
• D824TAB3RC0: Ø3.5mm x L3.0mm, Conical Connection, Regular Platform
• D824TAB3NC0: Ø3.0mm x L3.0mm, Conical Connection, Narrow Platform
• D824TAB2WC0: Ø4.3mm x L2.0mm, Conical Connection, Wide Platform
• D824TAB2RH0: Ø3.75mm x L2.0mm, Hex Connection, Regular Platform
• D824TAB2RC0: Ø3.5mm x L2.0mm, Conical Connection, Regular Platform
• D824TAB2NC0: Ø3.0mm x L2.0mm, Conical Connection, Narrow Platform
• D824TAB1WC0: Ø4.3mm x L1.0mm, Conical Connection, Wide Platform
• D824TAB1RH0: Ø3.75mm x L1.0mm, Hex Connection, Regular Platform
• D824TAB1RC0: Ø3.5mm x L1.0mm, Conical Connection, Regular Platform
• D824TAB1NC0: Ø3.0mm x L1.0mm, Conical Connection, Narrow Platform