IU SB Abutment_hex Φ6.0

GUDID 08800026103189

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026103189
• NIH Device Record Key: 43f66331-04b2-48a8-a36f-0b4f8dc7a8e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU SB Abutment_hex Φ6.0
• Version Model Number: IUSB6055H
• 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	08800026103189 [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

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

Moist Heat or Steam Sterilization

[08800026103189]

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_hex Φ6.0]

• 08800026103219: IUSB6067H
• 08800026103202: IUSB6065H
• 08800026103196: IUSB6057H
• 08800026103189: IUSB6055H
• 08800026103172: IUSB6047H
• 08800026103165: IUSB6045H
• 08800026103158: IUSB6037H
• 08800026103141: IUSB6035H
• 08800026103134: IUSB6027H
• 08800026103127: IUSB6025H
• 08800026103110: IUSB6017H
• 08800026103103: IUSB6015H