ETIII SA (Ø3.2mm) [ Implant Only ]

GUDID 00814913024356

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913024356
• NIH Device Record Key: 59a7b2e4-e608-42f3-b3ca-2e6f08c44a78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETIII SA (Ø3.2mm) [ Implant Only ]
• Version Model Number: ET3M3010S
• 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	00814913024356 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-08

On-Brand Devices [ETIII SA (Ø3.2mm) [ Implant Only ]]

• 00814913024387: ET3M3015S
• 00814913024370: ET3M3013S
• 00814913024363: ET3M3011S
• 00814913024356: ET3M3010S
• 00814913024349: ET3M3008S