ET ZIOCERA ABUTMENT

GUDID 00810019240997

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810019240997
• NIH Device Record Key: 18c731ad-b56c-48e7-ac1b-23e796b37e3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET ZIOCERA ABUTMENT
• Version Model Number: ETZCA453MHW
• 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: false
• 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	00810019240997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161689

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-23
• Device Publish Date: 2019-05-15

On-Brand Devices [ET ZIOCERA ABUTMENT]

• 00810019241147: ETZCA655SNW
• 00810019241130: ETZCA655SHW
• 00810019241123: ETZCA653SNW
• 00810019241116: ETZCA653SHW
• 00810019241109: ETZCA555SNW
• 00810019241093: ETZCA555SHW
• 00810019241086: ETZCA553SNW
• 00810019241079: ETZCA553SHW
• 00810019241062: ETZCA455SNW
• 00810019241055: ETZCA455SHW
• 00810019241048: ETZCA453SNW
• 00810019241031: ETZCA453SHW
• 00810019241024: ETZCA455MNW
• 00810019241017: ETZCA455MHW
• 00810019241000: ETZCA453MNW
• 00810019240997: ETZCA453MHW