Versatile Implant

GUDID D824VRH37130

Ø3.75mm x L13.0mm, Hex Connection, Regular Platform

SURGIKOR, LLC

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

• Primary Device ID: D824VRH37130
• NIH Device Record Key: 28449719-3b34-43e0-b935-5f11ffb0eb7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Versatile Implant
• Version Model Number: VRH3513
• 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	D824VRH37130 [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 [Versatile Implant ]

• D824VWC60160: Ø6.0mm x L16.0mm, Conical Connection, Wide Platform
• D824VWC60130: Ø6.0mm x L13.0mm, Conical Connection, Wide Platform
• D824VWC60110: Ø6.0mm x L11.5mm, Conical Connection, Wide Platform
• D824VWC60100: Ø6.0mm x L10.0mm, Conical Connection, Wide Platform
• D824VWC60080: Ø6.0mm x L8.0mm, Conical Connection, Wide Platform
• D824VWC50160: Ø5.0mm x L16.0mm, Conical Connection, Wide Platform
• D824VWC50130: Ø5.0mm x L13.0mm, Conical Connection, Wide Platform
• D824VWC50110: Ø5.0mm x L11.5mm, Conical Connection, Wide Platform
• D824VWC50100: Ø5.0mm x L10.0mm, Conical Connection, Wide Platform
• D824VWC50080: Ø5.0mm x L8.0mm, Conical Connection, Wide Platform
• D824VWC45160: Ø4.5mm x L16.0mm, Conical Connection, Wide Platform
• D824VWC45130: Ø4.5mm x L13.0mm, Conical Connection, Wide Platform
• D824VWC45110: Ø4.5mm x L11.5mm, Conical Connection, Wide Platform
• D824VWC45100: Ø4.5mm x L10.0mm, Conical Connection, Wide Platform
• D824VWC45080: Ø4.5mm x L8.0mm, Conical Connection, Wide Platform
• D824VWC42200: Ø4.2mm x L20.0mm, Conical Connection, Wide Platform
• D824VWC42180: Ø4.2mm x L18.0mm, Conical Connection, Wide Platform
• D824VWC42160: Ø4.2mm x L16.0mm, Conical Connection, Wide Platform
• D824VWC42130: Ø4.2mm x L13.0mm, Conical Connection, Wide Platform
• D824VWC42110: Ø4.2mm x L11.5mm, Conical Connection, Wide Platform
• D824VWC42100: Ø4.2mm x L10.0mm, Conical Connection, Wide Platform
• D824VWC42080: Ø4.2mm x L8.0mm, Conical Connection, Wide Platform
• D824VRH60160: Ø6.0mm x L16.0mm, Hex Connection, Regular Platform
• D824VRH60130: Ø6.0mm x L13.0mm, Hex Connection, Regular Platform
• D824VRH60110: Ø6.0mm x L11.5mm, Hex Connection, Regular Platform
• D824VRH60100: Ø6.0mm x L10.0mm, Hex Connection, Regular Platform
• D824VRH60080: Ø6.0mm x L8.0mm, Hex Connection, Regular Platform
• D824VRH50160: Ø5.0mm x L16.0mm, Hex Connection, Regular Platform
• D824VRH50130: Ø5.0mm x L13.0mm, Hex Connection, Regular Platform
• D824VRH50110: Ø5.0mm x L11.5mm, Hex Connection, Regular Platform
• D824VRH50100: Ø5.0mm x L10.0mm, Hex Connection, Regular Platform
• D824VRH50080: Ø5.0mm x L8.0mm, Hex Connection, Regular Platform
• D824VRH45160: Ø4.5mm x L16.0mm, Hex Connection, Regular Platform
• D824VRH45130: Ø4.5mm x L13.0mm, Hex Connection, Regular Platform
• D824VRH45110: Ø4.5mm x L11.5mm, Hex Connection, Regular Platform
• D824VRH45100: Ø4.5mm x L10.0mm, Hex Connection, Regular Platform
• D824VRH45080: Ø4.5mm x L8.0mm, Hex Connection, Regular Platform
• D824VRH42200: Ø4.2mm x L20.0mm, Hex Connection, Regular Platform
• D824VRH42180: Ø4.2mm x L18.0mm, Hex Connection, Regular Platform
• D824VRH42160: Ø4.2mm x L16.0mm, Hex Connection, Regular Platform
• D824VRH42130: Ø4.2mm x L13.0mm, Hex Connection, Regular Platform
• D824VRH42110: Ø4.2mm x L11.5mm, Hex Connection, Regular Platform
• D824VRH42100: Ø4.2mm x L10.0mm, Hex Connection, Regular Platform
• D824VRH42080: Ø4.2mm x L8.0mm, Hex Connection, Regular Platform
• D824VRH37160: Ø3.75mm x L16.0mm, Hex Connection, Regular Platform
• D824VRH37130: Ø3.75mm x L13.0mm, Hex Connection, Regular Platform
• D824VRH37110: Ø3.75mm x L11.5mm, Hex Connection, Regular Platform
• D824VRH37100: Ø3.75mm x L10.0mm, Hex Connection, Regular Platform
• D824VRH37080: Ø3.75mm x L8.0mm, Hex Connection, Regular Platform
• D824VRH35160: Ø3.5mm x L16.0mm, Hex Connection, Regular Platform