IU Top Abutment_hex Φ3.8

GUDID 08800026123378

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026123378
• NIH Device Record Key: 6cb1435c-ee9b-4e07-a36f-6c77330b687a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU Top Abutment_hex Φ3.8
• Version Model Number: I0UTA3864HA
• Company DUNS: 688857820
• Company Name: WARANTEC.Co.,Ltd
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800026123378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172345

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

[08800026123378]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-20
• Device Publish Date: 2023-04-12

On-Brand Devices [IU Top Abutment_hex Φ3.8]

• 08800026123422: I0UTA3856HA
• 08800026123415: I0UTA3846HA
• 08800026123408: I0UTA3836HA
• 08800026123392: I0UTA3826HA
• 08800026123385: I0UTA3816HA
• 08800026123378: I0UTA3864HA
• 08800026123361: I0UTA3854HA
• 08800026123354: I0UTA3844HA
• 08800026123347: I0UTA3824HA
• 08800026123330: I0UTA3814HA
• 08800026115809: I0UTA3834HA
• 08800026112983: I0UTA3866HA