Cover screw

GUDID D824CSH0

Cover Screw Hex Connection

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824CSH0
• NIH Device Record Key: 6bdc5a2b-1f14-42bc-be38-587de33149fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cover screw
• Version Model Number: CSH
• 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: 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	D824CSH0 [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 [Cover screw]

• D824CSH0: Cover Screw Hex Connection
• D824CSCW0: Cover Screw Conical Connection Wide
• D824CSCR0: Cover Screw Conical Connection
• D824CSCN0: Cover Screw Conical Connection Narrow