IU Ball Attachment Abutment

GUDID 08800026104391

WARANTEC.Co.,Ltd

Dental implant system

• Primary Device ID: 08800026104391
• NIH Device Record Key: 5c0f0239-24f0-4b35-804f-cf60cbaa4152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IU Ball Attachment Abutment
• Version Model Number: IUBA5040
• 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	08800026104391 [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

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

Moist Heat or Steam Sterilization

[08800026104391]

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 Ball Attachment Abutment]

• 08800026104414: IUBA5060
• 08800026104407: IUBA5050
• 08800026104391: IUBA5040
• 08800026104384: IUBA5030
• 08800026104377: IUBA5020
• 08800026104360: IUBA5010
• 08800026104353: IUBA4060A
• 08800026104346: IUBA4050A
• 08800026104339: IUBA4040A
• 08800026104322: IUBA4030A
• 08800026104315: IUBA4020A
• 08800026104308: IUBA4010A