Immediate Implant Pack

GUDID D824PIRC35161

Ø3.5mm x L16.0mm, Conical Connection, Regular Platform with Cover Screw & Mount

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824PIRC35161
• NIH Device Record Key: de2e8b2f-1968-400f-a379-70180440e7bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immediate Implant Pack
• Version Model Number: PIRC3516
• 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: true
• 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	D824PIRC35160 [Primary]
HIBCC	D824PIRC35161 [Package]; Contains: D824PIRC35160; Package: [10 Units]; In Commercial Distribution

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: 2017-02-07

On-Brand Devices [Immediate Implant Pack]

• D824PIWC80082: Ø8.0mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC80062: Ø8.0mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC70102: Ø7.0mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC70082: Ø7.0mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC70062: Ø7.0mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC60162: Ø6.0mm x L16.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC60132: Ø6.0mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC60112: Ø6.0mm x L11.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC60102: Ø6.0mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC60082: Ø6.0mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC60062: Ø6.0mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC50162: Ø5.0mm x L16.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC50132: Ø5.0mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC50112: Ø5.0mm x L11.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC50102: Ø5.0mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC50082: Ø5.0mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC50062: Ø5.0mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC45162: Ø4.5mm x L16.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC45132: Ø4.5mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC45112: Ø4.5mm x L11.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC45102: Ø4.5mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC45082: Ø4.5mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC45062: Ø4.5mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC42162: Ø4.2mm x L16.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC42132: Ø4.2mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC42112: Ø4.2mm x L11.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC42102: Ø4.2mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIWC42082: Ø4.2mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PIRH80102: Ø8.0mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH80082: Ø8.0mm x L8.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH80062: Ø8.0mm x L6.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH70102: Ø7.0mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH70082: Ø7.0mm x L8.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH70062: Ø7.0mm x L6.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH60162: Ø6.0mm x L16.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH60131: Ø6.0mm x L13.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH60112: Ø6.0mm x L11.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH60102: Ø6.0mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH60082: Ø6.0mm x L8.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH60062: Ø6.0mm x L6.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH50162: Ø5.0mm x L16.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH50132: Ø5.0mm x L13.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH50112: Ø5.0mm x L11.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH50102: Ø5.0mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH50082: Ø5.0mm x L8.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH50062: Ø5.0mm x L6.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH45162: Ø4.5mm x L16.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH45132: Ø4.5mm x L13.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH45112: Ø4.5mm x L11.0mm, Hex Connection, Regular Platform with Cover Screw & Mount
• D824PIRH45102: Ø4.5mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount