Abutment regular screw

GUDID D824SCHR0

Abutment regular screw for Connical Connection M-2

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824SCHR0
• NIH Device Record Key: 3e5bae81-144d-4eb4-9ac3-b32326dacbed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Abutment regular screw
• Version Model Number: SCHr
• 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: false
• 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	D824SCHR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152555

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D824SCHR0]

Moist Heat or Steam Sterilization

[D824SCHR0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-06

On-Brand Devices [Abutment regular screw]

• D824SCHSH0: Abutment short screw for Hex Connection
• D824SCHR0: Abutment regular screw for Connical Connection M-2
• D824SCCWR0: Abutment regular screw for Connical connection M-2
• D824SCCRR0: Abutment regular screw for Connical connection M1.6
• D824SCCNR0: Abutment regular screw for Connical connection M1.4