Solution5 Implant

GUDID D824S5NC32110

Ø3.25mm x L11.5mm, Conical Connection, Narrow Platform

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824S5NC32110
• NIH Device Record Key: abe55d90-aad5-4f2a-833d-e07266ad0105
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solution5 Implant
• Version Model Number: S5NC3211
• 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	D824S5NC32110 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-31

On-Brand Devices [Solution5 Implant]

• D824S5WC50150: Ø5.0mm x L15.0 mm, Conical Connection, Wide Platform
• D824S5WC50130: Ø5.0mm x L13.0 mm, Conical Connection, Wide Platform
• D824S5WC50110: Ø5.0mm x L11.5 mm, Conical Connection, Wide Platform
• D824S5WC50100: Ø5.0mm x L10.0 mm, Conical Connection, Wide Platform
• D824S5WC50080: Ø5.0mm x L8.5 mm, Conical Connection, Wide Platform
• D824S5WC50070: Ø5.0mm x L7.0 mm, Conical Connection, Wide Platform
• D824S5WC45150: Ø4.5mm x L15.0 mm, Conical Connection, Wide Platform
• D824S5WC45130: Ø4.5mm x L13.0 mm, Conical Connection, Wide Platform
• D824S5WC45110: Ø4.5mm x L11.5 mm, Conical Connection, Wide Platform
• D824S5WC45100: Ø4.5mm x L10.0 mm, Conical Connection, Wide Platform
• D824S5WC45080: Ø4.5mm x L8.5 mm, Conical Connection, Wide Platform
• D824S5WC45070: Ø4.5mm x L7.0 mm, Conical Connection, Wide Platform
• D824S5WC40150: Ø4.0mm x L15.0 mm, Conical Connection, Wide Platform
• D824S5WC40130: Ø4.0mm x L13.0 mm, Conical Connection, Wide Platform
• D824S5WC40110: Ø4.0mm x L11.5 mm, Conical Connection, Wide Platform
• D824S5WC40100: Ø4.0mm x L10.0 mm, Conical Connection, Wide Platform
• D824S5WC40080: Ø4.0mm x L8.5 mm, Conical Connection, Wide Platform
• D824S5WC40070: Ø4.0mm x L7.0 mm, Conical Connection, Wide Platform
• D824S5RC35150: Ø3.5mm x L15.0mm, Conical Connection, Regular Platform
• D824S5RC35130: Ø3.5mm x L13.0mm, Conical Connection, Regular Platform
• D824S5RC35110: Ø3.5mm x L11.5.0mm, Conical Connection, Regular Platform
• D824S5RC35100: Ø3.5mm x L10.0mm, Conical Connection, Regular Platform
• D824S5RC35080: Ø3.5mm x L8.5 mm, Conical Connection, Regular Platform
• D824S5NC32160: Ø3.25mm x L16.0mm, Conical Connection, Narrow Platform
• D824S5NC32130: Ø3.25mm x L13.0mm, Conical Connection, Narrow Platform
• D824S5NC32110: Ø3.25mm x L11.5mm, Conical Connection, Narrow Platform
• D824S5NC32100: Ø3.25mm x L10.0mm, Conical Connection, Narrow Platform
• D824S5NC30160: Ø3.0mm x L16.0mm, Conical Connection, Narrow Platform
• D824S5NC30130: Ø3.0mm x L13.0mm, Conical Connection, Narrow Platform
• D824S5NC30110: Ø3.0mm x L11.5mm, Conical Connection, Narrow Platform
• D824S5NC30100: Ø3.0mm x L10.0mm, Conical Connection, Narrow Platform
• D824S2NC32160: Ø3.25mm x L16.0mm, Conical Connection, Narrow Platform
• D824S2NC32130: Ø3.25mm x L13.0mm, Conical Connection, Narrow Platform
• D824S2NC32110: Ø3.25mm x L11.5mm, Conical Connection, Narrow Platform
• D824S2NC32100: Ø3.25mm x L10.0mm, Conical Connection, Narrow Platform
• D824S5WC60150: Ø6.0mm x L15.0mm, Conical Connection, Wide Platform
• D824S5WC60130: Ø6.0mm x L13.0mm, Conical Connection, Wide Platform
• D824S5WC60110: Ø6.0mm x L11.5mm, Conical Connection, Wide Platform
• D824S5WC60100: Ø6.0mm x L10.0mm, Conical Connection, Wide Platform
• D824S5WC60080: Ø6.0mm x L8.5mm, Conical Connection, Wide Platform
• D824S5WC60070: Ø6.0mm x L7.0mm, Conical Connection, Wide Platform
• D824S5WC55150: Ø5.5mm x L15.0mm, Conical Connection, Wide Platform
• D824S5WC55130: Ø5.5mm x L13.0mm, Conical Connection, Wide Platform
• D824S5WC55110: Ø5.5mm x L11.5mm, Conical Connection, Wide Platform
• D824S5WC55100: Ø5.5mm x L10.0mm, Conical Connection, Wide Platform
• D824S5WC55080: Ø5.5mm x L8.5mm, Conical Connection, Wide Platform
• D824S5WC55070: Ø5.5mm x L7.0mm, Conical Connection, Wide Platform
• D824S5RC40150: Ø4.0mm x L15.0mm, Conical Connection, Regular Platform
• D824S5RC40130: Ø4.0mm x L13.0mm, Conical Connection, Regular Platform
• D824S5RC40110: Ø4.0mm x L11.5mm, Conical Connection, Regular Platform