Fixation Implant Pack

GUDID D824PFRC35082

Ø3.5mm x L8.5mm, Conical Connection, Regular Platform with Cover Screw & Mount

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824PFRC35082
• NIH Device Record Key: 2c66df94-5015-4221-80d5-72e80be76262
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixation Implant Pack
• Version Model Number: PFRC3508
• 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: false
• 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	D824PFRC35080 [Primary]
HIBCC	D824PFRC35081 [Package]; Contains: D824PFRC35080; Package: [10 Units]; In Commercial Distribution
HIBCC	D824PFRC35082 [Package]; Contains: D824PFRC35080; Package: [4 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: 2017-01-31

On-Brand Devices [Fixation Implant Pack]

• D824PFWC50182: Ø5.0mm x L18.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC50152: Ø5.0mm x L15.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC50132: Ø5.0mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC50112: Ø5.0mm x L11.5mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC50102: Ø5.0mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC50082: Ø5.0mm x L8.5mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC43182: Ø4.3mm x L18.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC43152: Ø4.3mm x L15.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC43132: Ø4.3mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC43112: Ø4.3mm x L11.5mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC43102: Ø4.3mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFWC43082: Ø4.3mm x L8.5mm, Conical Connection, Wide Platform with Cover Screw & Mount
• D824PFRC35182: Ø3.5mm x L18.0mm, Conical Connection, Regular Platform with Cover Screw & Mount
• D824PFRC35152: Ø3.5mm x L15.0mm, Conical Connection, Regular Platform with Cover Screw & Mount
• D824PFRC35132: Ø3.5mm x L13.0mm, Conical Connection, Regular Platform with Cover Screw & Mount
• D824PFRC35112: Ø3.5mm x L11.5mm, Conical Connection, Regular Platform with Cover Screw & Mount
• D824PFRC35102: Ø3.5mm x L10.0mm, Conical Connection, Regular Platform with Cover Screw & Mount
• D824PFRC35082: Ø3.5mm x L8.5mm, Conical Connection, Regular Platform with Cover Screw & Mount
• D824PFNC30152: Ø3.0mm x L15.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount
• D824PFNC30132: Ø3.0mm x L13.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount
• D824PFNC30112: Ø3.0mm x L11.5mm, Conical Connection, Narrow Platform with Cover Screw & Mount
• D824PFNC30102: Ø3.0mm x L10mm, Conical Connection, Narrow Platform with Cover Screw & Mount