Screw for open tray

GUDID D824SCH2OP0

Titanium Screw for Open Tray Hex connection

SURGIKOR, LLC

Basket endosteal dental implant, two-piece

• Primary Device ID: D824SCH2OP0
• NIH Device Record Key: 32c032c9-9d38-4001-8605-7a76449ba6a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Screw for open tray
• Version Model Number: SCH2op
• 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	D824SCH2OP0 [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

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

Moist Heat or Steam Sterilization

[D824SCH2OP0]

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 [Screw for open tray]

• D824SCH2OP0: Titanium Screw for Open Tray Hex connection
• D824SCCWOP0: Titanium Screw for Open Tray Connical Connection M-2
• D824SCCROP0: Titanium Screw for Open Tray Connical Connection M1.6
• D824SCCNOP0: Titanium Screw for Open Tray Connical Connection M1.4