ET III SA Ultra-Wide Fixture Pre-Mounted

GUDID 00814913020914

HIOSSEN, INC.

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

• Primary Device ID: 00814913020914
• NIH Device Record Key: ae75b356-5a0b-47a6-a220-d17322dd23af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III SA Ultra-Wide Fixture Pre-Mounted
• Version Model Number: AET3R7007S
• 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	00814913020914 [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: 2015-09-01

On-Brand Devices [ET III SA Ultra-Wide Fixture Pre-Mounted]

• 00814913020952: AET3R7013S
• 00814913020945: AET3R7011S
• 00814913020938: AET3R7010S
• 00814913020921: AET3R7008S
• 00814913020914: AET3R7007S
• 00814913020907: AET3R7006S
• 00814913020891: AET3R6013S
• 00814913020884: AET3R6011S
• 00814913020877: AET3R6010S
• 00814913020860: AET3R6008S
• 00814913020853: AET3R6007S
• 00814913020846: AET3R6006S