IU SB Abutment Φ5.0

GUDID 08800026103561

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026103561
• NIH Device Record Key: 0f46770d-65cd-4691-b437-c604a2fcf3c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU SB Abutment Φ5.0
• Version Model Number: IUSB5065
• 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	08800026103561 [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

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

Moist Heat or Steam Sterilization

[08800026103561]

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 Φ5.0]

• 08800026108894: IUSB5064
• 08800026108887: IUSB5054
• 08800026108870: IUSB5044
• 08800026108863: IUSB5034
• 08800026108856: IUSB5024
• 08800026108849: IUSB5014
• 08800026103578: IUSB5067
• 08800026103561: IUSB5065
• 08800026103554: IUSB5057
• 08800026103547: IUSB5055
• 08800026103530: IUSB5047
• 08800026103523: IUSB5045
• 08800026103516: IUSB5037
• 08800026103509: IUSB5035
• 08800026103493: IUSB5027
• 08800026103486: IUSB5025
• 08800026103479: IUSB5017
• 08800026103462: IUSB5015