ET TEMPORARY ABUTMENT

GUDID 00814913028590

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00814913028590
• NIH Device Record Key: 8b1e9221-612b-4122-bce5-1ee8b25b65c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET TEMPORARY ABUTMENT
• Version Model Number: ETTPA403MNT
• 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	00814913028590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110308

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 TEMPORARY ABUTMENT]

• 00814913028637: ETTPA453SNT
• 00814913028620: ETTPA453SHT
• 00814913028613: ETTPA451SNT
• 00814913028606: ETTPA451SHT
• 00814913028590: ETTPA403MNT
• 00814913028583: ETTPA403MHT
• 00814913028576: ETTPA401MNT
• 00814913028569: ETTPA401MHT