ET III SA Ultra-Wide Fixture No Mount

GUDID 00814913024905

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913024905
• NIH Device Record Key: 47b3d3fc-dedf-4068-8dea-38c4ce04855d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III SA Ultra-Wide Fixture No Mount
• Version Model Number: AET3R6013S
• 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	00814913024905 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-15

On-Brand Devices [ET III SA Ultra-Wide Fixture No Mount]

• 00814913024967: CET3R7013S
• 00814913024950: CET3R7011S
• 00814913024943: CET3R7010S
• 00814913024936: CET3R7008S
• 00814913024929: CET3R7007S
• 00814913024912: CET3R7006S
• 00814913024905: AET3R6013S
• 00814913024899: CET3R6011S
• 00814913024882: CET3R6010S
• 00814913024875: CET3R6008S
• 00814913024868: CET3R6007S
• 00814913024851: CET3R6006S