HIOSSEN

GUDID 00814913020006

HIOSSEN, INC.

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

• Primary Device ID: 00814913020006
• NIH Device Record Key: 07118079-62c3-4be7-99e8-11fdf26670b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIOSSEN
• Version Model Number: AET3M3508B
• 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	00814913020006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112532

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: 2015-07-31

On-Brand Devices [HIOSSEN]

• 00814913020556: AET3M3015S
• 00814913020549: AET3M3013S
• 00814913020532: AET3M3011S
• 00814913020525: AET3M3010S
• 00814913020518: AET3M3008S
• 00814913020006: AET3M3508B