ET IV Fixture SA Regular Pre-Mounted

GUDID 00814913029191

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913029191
• NIH Device Record Key: 5c90828d-3f06-4ed2-96c7-569fb01dc232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET IV Fixture SA Regular Pre-Mounted
• Version Model Number: AET4R4511S
• 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	00814913029191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183242

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-18
• Device Publish Date: 2019-07-10

On-Brand Devices [ET IV Fixture SA Regular Pre-Mounted]

• 00814913029252: AET4R5013S
• 00814913029245: AET4R5011S
• 00814913029238: AET4R5010S
• 00814913029221: AET4R5008S
• 00814913029214: AET4R5007S
• 00814913029207: AET4R4513S
• 00814913029191: AET4R4511S
• 00814913029184: AET4R4510S
• 00814913029177: AET4R4508S
• 00814913029160: AET4R4507S
• 00814913029153: AET4R4013S
• 00814913029146: AET4R4011S
• 00814913029139: AET4R4010S
• 00814913029122: AET4R4008S
• 00814913029115: AET4R4007S