OMNI Straight Fixture

GUDID 08800076400047

Truabutment Korea Co.,Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800076400047
• NIH Device Record Key: df2ad8f9-c180-4e18-a76f-c52708cea843
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI Straight Fixture
• Version Model Number: OMF30145
• Company DUNS: 694514760
• Company Name: Truabutment Korea Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800076400047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200817

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-29
• Device Publish Date: 2026-01-21

On-Brand Devices [OMNI Straight Fixture]

• 08800076400047: OMF30145
• 08800076400030: OMF30130
• 08800076400023: OMF30115
• 08800076400016: OMF30100