OMNI Fixture

GUDID 08800076400269

Truabutment Korea Co.,Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800076400269
• NIH Device Record Key: 10ec3495-0c12-4c00-9da8-33ba0c50c6c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI Fixture
• Version Model Number: OMF50130
• 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	08800076400269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172100

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: 2026-01-27
• Device Publish Date: 2026-01-19

On-Brand Devices [OMNI Fixture]

• 08800076400399: OMF65100
• 08800076400382: OMF65085
• 08800076400375: OMF65070
• 08800076400368: OMF60100
• 08800076400351: OMF60085
• 08800076400344: OMF60070
• 08800076400337: OMF55145
• 08800076400320: OMF55130
• 08800076400313: OMF55115
• 08800076400306: OMF55100
• 08800076400290: OMF55085
• 08800076400283: OMF55070
• 08800076400276: OMF50145
• 08800076400269: OMF50130
• 08800076400252: OMF50115
• 08800076400245: OMF50100
• 08800076400238: OMF50085
• 08800076400221: OMF50070
• 08800076400214: OMF45145
• 08800076400207: OMF45130
• 08800076400191: OMF45115
• 08800076400184: OMF45100
• 08800076400177: OMF45085
• 08800076400160: OMF45070
• 08800076400153: OMF40145
• 08800076400146: OMF40130
• 08800076400139: OMF40115
• 08800076400122: OMF40100
• 08800076400115: OMF40085
• 08800076400108: OMF40070
• 08800076400092: OMF35145
• 08800076400085: OMF35130
• 08800076400078: OMF35115
• 08800076400061: OMF35100
• 08800076400054: OMF35085