ET III Fixture SA Mini No Mount

GUDID 00814913020969

HIOSSEN, INC.

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

• Primary Device ID: 00814913020969
• NIH Device Record Key: 7653b660-c8fd-4c64-a46f-fc83cdd6935e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture SA Mini No Mount
• Version Model Number: CET3M3508S
• 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	00814913020969 [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 Fixture SA Mini No Mount]

• 00814913021003: CET3M3515S
• 00814913020990: CET3M3513S
• 00814913020983: CET3M3511S
• 00814913020976: CET3M3510S
• 00814913020969: CET3M3508S