EK Onefit Abutment

GUDID 00810125999161

HIOSSEN, INC.

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• Primary Device ID: 00810125999161
• NIH Device Record Key: 50a43845-ec4b-40df-a6e1-6883f6785a15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EK Onefit Abutment
• Version Model Number: EKCMANT
• Company DUNS: 796083090
• Company Name: HIOSSEN, INC.
• 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: 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	00810125999161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233389

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-25
• Device Publish Date: 2024-06-17

Devices Manufactured by HIOSSEN, INC.

• 00810125999154 - EK Onefit Abutment: 2024-06-25
• 00810125999161 - EK Onefit Abutment: 2024-06-25
• 00810125999161 - EK Onefit Abutment: 2024-06-25
• 00810125999178 - EK Onefit Abutment(Gold): 2024-06-25
• 00810125999185 - EK Onefit Abutment(Gold): 2024-06-25
• 00810125999192 - EK New scan body: 2024-06-25
• 00810125999208 - EK New scan body: 2024-06-25
• 00810125999215 - EK New scan body: 2024-06-25
• 00810125999116 - ET Multi Angled Abutment: 2024-05-15