ET III Fixture SA Mini [ Implant Only]

GUDID 00814913029764

HIOSSEN, INC.

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• Primary Device ID: 00814913029764
• NIH Device Record Key: 26410396-4a27-4865-80b9-8295191fd1e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture SA Mini [ Implant Only]
• Version Model Number: ET3M3511S
• 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	00814913029764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140934

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: 2024-03-26
• Device Publish Date: 2024-03-18

On-Brand Devices [ET III Fixture SA Mini [ Implant Only]]

• 00814913029788: ET3M3515S
• 00814913029771: ET3M3513S
• 00814913029764: ET3M3511S
• 00814913029757: ET3M3510S
• 00814913029740: ET3M3508S