IU SB Abutment_hex Φ5.0

GUDID 08800026109259

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026109259
• NIH Device Record Key: 131c557f-9f27-4adc-b17c-7de29683414a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU SB Abutment_hex Φ5.0
• Version Model Number: IUSB5034H
• 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	08800026109259 [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

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

Moist Heat or Steam Sterilization

[08800026109259]

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 Φ5.0]

• 08800026109280: IUSB5064H
• 08800026109273: IUSB5054H
• 08800026109266: IUSB5044H
• 08800026109259: IUSB5034H
• 08800026109242: IUSB5024H
• 08800026109235: IUSB5014H
• 08800026103097: IUSB5067H
• 08800026103080: IUSB5065H
• 08800026103073: IUSB5057H
• 08800026103066: IUSB5055H
• 08800026103059: IUSB5047H
• 08800026103042: IUSB5045H
• 08800026103035: IUSB5037H
• 08800026103028: IUSB5035H
• 08800026103011: IUSB5027H
• 08800026103004: IUSB5025H
• 08800026102991: IUSB5017H
• 08800026102984: IUSB5015H