ET III Fixture NH Mini D3.2Pre-Mounted

GUDID 00814913028774

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913028774
• NIH Device Record Key: cf56797c-d26c-4f62-89c8-64ad898f4c79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture NH Mini D3.2Pre-Mounted
• Version Model Number: AET3M3010B
• 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	00814913028774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153332

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: 2019-03-11
• Device Publish Date: 2019-02-28

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