IU SB Abutment Φ4.0

GUDID 08800026103400

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026103400
• NIH Device Record Key: eecccea2-1e8c-4a0b-a34c-0760dd269a12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU SB Abutment Φ4.0
• Version Model Number: IUSB4045
• 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	08800026103400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172345

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

Moist Heat or Steam Sterilization

[08800026103400]

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 SB Abutment Φ4.0]

• 08800026108832: IUSB4064A
• 08800026108825: IUSB4064
• 08800026108818: IUSB4054A
• 08800026108801: IUSB4054
• 08800026108795: IUSB4044A
• 08800026108788: IUSB4044
• 08800026108771: IUSB4034A
• 08800026108764: IUSB4034
• 08800026108757: IUSB4024A
• 08800026108740: IUSB4024
• 08800026108733: IUSB4014A
• 08800026108726: IUSB4014
• 08800026103813: IUSB4067A
• 08800026103806: IUSB4065A
• 08800026103790: IUSB4057A
• 08800026103783: IUSB4055A
• 08800026103776: IUSB4047A
• 08800026103769: IUSB4045A
• 08800026103752: IUSB4037A
• 08800026103745: IUSB4035A
• 08800026103738: IUSB4027A
• 08800026103721: IUSB4025A
• 08800026103714: IUSB4017A
• 08800026103707: IUSB4015A
• 08800026103448: IUSB4065
• 08800026103431: IUSB4057
• 08800026103424: IUSB4055
• 08800026103417: IUSB4047
• 08800026103400: IUSB4045
• 08800026103394: IUSB4037
• 08800026103387: IUSB4035
• 08800026103370: IUSB4027
• 08800026103363: IUSB4025
• 08800026103356: IUSB4017
• 08800026103349: IUSB4015