]ET III Fixture SA Regular [ Implant Only]

GUDID 00814913029948

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913029948
• NIH Device Record Key: 22bab8d3-4ac5-474e-9d51-bfa2263382a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ]ET III Fixture SA Regular [ Implant Only]
• Version Model Number: ET3R5011S
• 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	00814913029948 [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

Devices Manufactured by HIOSSEN, INC.

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• 00810126043511 - ET III Fixture SA Regular Pre-Mounted: 2025-10-07
• 00810126043528 - ET III Fixture NH Regular Pre-Mounted: 2025-10-07
• 00810126043580 - ET III Fixture SA Regular Pre-Mounted: 2025-10-07
• 00810126043597 - ET III Fixture NH Regular Pre-Mounted: 2025-10-07
• 00810126043603 - ET III Fixture SA Regular Pre-Mounted: 2025-10-07