ET II Fixture SA Mini Pre-Mounted

GUDID 00814913020259

HIOSSEN, INC.

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

• Primary Device ID: 00814913020259
• NIH Device Record Key: 64531e38-9c14-435c-8464-59bb0a705bf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET II Fixture SA Mini Pre-Mounted
• Version Model Number: AET2M3511S
• 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	00814913020259 [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 II Fixture SA Mini Pre-Mounted]

• 00814913020280: AET2M3518S
• 00814913020273: AET2M3515S
• 00814913020266: AET2M3513S
• 00814913020259: AET2M3511S
• 00814913020242: AET2M3510S
• 00814913020235: AET2M3508S