ET III Fixture BA Mini Pre-Mounted

GUDID 00814913020013

HIOSSEN, INC.

Dental implant system Dental implant system

• Primary Device ID: 00814913020013
• NIH Device Record Key: d0226581-35be-42d7-9a88-30cd59b997df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET III Fixture BA Mini Pre-Mounted
• Version Model Number: AET3M3510B
• 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	00814913020013 [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: 2015-09-01

On-Brand Devices [ET III Fixture BA Mini Pre-Mounted]

• 00814913020044: AET3M3515B
• 00814913020037: AET3M3513B
• 00814913020020: AET3M3511B
• 00814913020013: AET3M3510B