URIS OMNI Straight Fixture

GUDID 08800076460645

Truabutment Korea Co.,Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800076460645
• NIH Device Record Key: 79f33e22-954e-4a78-99f1-742d0f1100e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URIS OMNI Straight Fixture
• Version Model Number: OMF45180
• 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	08800076460645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243255

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: 2026-02-03
• Device Publish Date: 2026-01-26

On-Brand Devices [URIS OMNI Straight Fixture]

• 08800076460645: OMF45180
• 08800076460638: OMF45160
• 08800076460621: OMF40180
• 08800076460614: OMF40160
• 08800076460607: OMF35180
• 08800076460591: OMF35160