ET III Fixture SA Regular [ Implant Only]

GUDID 00814913029900

HIOSSEN, INC.

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• Primary Device ID: 00814913029900
• NIH Device Record Key: f164c03e-d7c0-4c6e-b75c-1e941aca4c89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture SA Regular [ Implant Only]
• Version Model Number: ET3R4515S
• 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	00814913029900 [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 Regular [ Implant Only]]

• 00814913029962: ET3R5015S
• 00814913029955: ET3R5013S
• 00814913029931: ET3R5010S
• 00814913029924: ET3R5008S
• 00814913029917: ET3R5007S
• 00814913029900: ET3R4515S
• 00814913029894: ET3R4513S
• 00814913029887: ET3R4511S
• 00814913029870: ET3R4510S
• 00814913029863: ET3R4508S
• 00814913029856: ET3R4507S
• 00814913029849: ET3R4015S
• 00814913029832: ET3R4013S
• 00814913029825: ET3R4011S
• 00814913029818: ET3R4010S
• 00814913029801: ET3R4008S
• 00814913029795: ET3R4007S