Immediate Implant

GUDID D824IWC70110

Ø7.0mm x L11.5mm, Conical Connection, Wide Platform

SURGIKOR, LLC

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• Primary Device ID: D824IWC70110
• NIH Device Record Key: f041130d-2f01-40f2-9f73-15a5275fd4ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immediate Implant
• Version Model Number: IWC7011
• 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	D824IWC70110 [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: 2022-07-28
• Device Publish Date: 2022-07-20

On-Brand Devices [Immediate Implant ]

• D824IWC80100: Ø8.0mm x L10.0mm, Conical Connection, Wide Platform
• D824IWC80080: Ø8.0mm x L8.0mm, Conical Connection, Wide Platform
• D824IWC80060: Ø8.0mm x L6.0mm, Conical Connection, Wide Platform
• D824IWC70100: Ø7.0mm x L10.0mm, Conical Connection, Wide Platform
• D824IWC70080: Ø7.0mm x L8.0mm, Conical Connection, Wide Platform
• D824IWC70060: Ø7.0mm x L6.0mm, Conical Connection, Wide Platform
• D824IWC60160: Ø6.0mm x L16.0mm, Conical Connection, Wide Platform
• D824IWC60130: Ø6.0mm x L13.0mm, Conical Connection, Wide Platform
• D824IWC60110: Ø6.0mm x L11.5mm, Conical Connection, Wide Platform
• D824IWC60100: Ø6.0mm x L10.0mm, Conical Connection, Wide Platform
• D824IWC60080: Ø6.0mm x L8.0mm, Conical Connection, Wide Platform
• D824IWC60060: Ø6.0mm x L6.0mm, Conical Connection, Wide Platform
• D824IWC50160: Ø5.0mm x L16.0mm, Conical Connection, Wide Platform
• D824IWC50130: Ø5.0mm x L13mm, Conical Connection, Wide Platform
• D824IWC50110: Ø5.0mm x L11.5mm, Conical Connection, Wide Platform
• D824IWC50100: Ø5.0mm x L10.0mm, Conical Connection, Wide Platform
• D824IWC50080: Ø5.0mm x L8.0mm, Conical Connection, Wide Platform
• D824IWC50060: Ø5.0mm x L6.0mm, Conical Connection, Wide Platform
• D824IWC45160: Ø4.5mm x L16.0mm, Conical Connection, Wide Platform
• D824IWC45130: Ø4.5mm x L13.0mm, Conical Connection, Wide Platform
• D824IWC45110: Ø4.5mm x L11.5mm, Conical Connection, Wide Platform
• D824IWC45100: Ø4.5mm x L10.0mm, Conical Connection, Wide Platform
• D824IWC45080: Ø4.5mm x L8.0mm, Conical Connection, Wide Platform
• D824IWC45060: Ø4.5mm x L6.0mm, Conical Connection, Wide Platform
• D824IWC42160: Ø4.2mm x L16.0mm, Conical Connection, Wide Platform
• D824IWC42130: Ø4.2mm x L13.0mm, Conical Connection, Wide Platform
• D824IWC42110: Ø4.2mm x L11.5mm, Conical Connection, Wide Platform
• D824IWC42100: Ø4.2mm x L10.0mm, Conical Connection, Wide Platform
• D824IWC42080: Ø4.2mm x L8.0mm, Conical Connection, Wide Platform
• D824IRH80100: Ø8.0mm x L10.0mm, Hex Connection, Regular Platform
• D824IRH80080: Ø8.0mm x L8.0mm, Hex Connection, Regular Platform
• D824IRH80060: Ø8.0mm x L6.0mm, Hex Connection, Regular Platform
• D824IRH70100: Ø7.0mm x L10.0mm, Hex Connection, Regular Platform
• D824IRH70080: Ø7.0mm x L8.0mm, Hex Connection, Regular Platform
• D824IRH70060: Ø7.0mm x L6.0mm, Hex Connection, Regular Platform
• D824IRH60160: Ø6.0mm x L16.0mm, Hex Connection, Regular Platform
• D824IRH60130: Ø6.0mm x L13.0mm, Hex Connection, Regular Platform
• D824IRH60110: Ø6.0mm x L11.5mm, Hex Connection, Regular Platform
• D824IRH60100: Ø6.0mm x L10.0mm, Hex Connection, Regular Platform
• D824IRH60080: Ø6.0mm x L8.0mm, Hex Connection, Regular Platform
• D824IRH60060: Ø6.0mm x L6.0mm, Hex Connection, Regular Platform
• D824IRH50160: Ø5.0mm x L16.0mm, Hex Connection, Regular Platform
• D824IRH50130: Ø5.0mm x L13.0mm, Hex Connection, Regular Platform
• D824IRH50110: Ø5.0mm x L11.5mm, Hex Connection, Regular Platform
• D824IRH50100: Ø5.0mm x L10.0mm, Hex Connection, Regular Platform
• D824IRH50080: Ø5.0mm x L8.0mm, Hex Connection, Regular Platform
• D824IRH50060: Ø5.0mm x L6.0mm, Hex Connection, Regular Platform
• D824IRH45160: Ø4.5mm x L16.0mm, Hex Connection, Regular Platform
• D824IRH45130: Ø4.5mm x L13.0mm, Hex Connection, Regular Platform
• D824IRH45110: Ø4.5mm x L11.5mm, Hex Connection, Regular Platform