ET Temporary Abutment SET

GUDID 00810125995354

HIOSSEN, INC.

Screw endosteal dental implant, two-piece

• Primary Device ID: 00810125995354
• NIH Device Record Key: b59fc43f-8204-4e24-a97e-4adbe9336781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ET Temporary Abutment SET
• Version Model Number: ETTTA4510NCTH
• 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	00810125995354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222636

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: 2024-07-01
• Device Publish Date: 2024-06-21

On-Brand Devices [ET Temporary Abutment SET]

• 00810125995378: ETTTA4530NCTH
• 00810125995361: ETTTA4530CTH
• 00810125995354: ETTTA4510NCTH
• 00810125995347: ETTTA4510CTH
• 00810125995330: ETTTA4030NCTH
• 00810125995323: ETTTA4030CTH
• 00810125995316: ETTTA4010CTH
• 00810125995309: ETTTA4010CTH