Ball Abutment UNSBA 3510

GUDID 08800049271735

DIO Corporation

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800049271735
• NIH Device Record Key: 35ca374c-4223-41e1-b277-b8b75de69134
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ball Abutment
• Version Model Number: UNSBA 3510
• Catalog Number: UNSBA 3510
• Company DUNS: 631085206
• Company Name: DIO Corporation
• 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: true
• 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	08800049271735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161987

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800049271735]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-18
• Device Publish Date: 2020-03-10

Devices Manufactured by DIO Corporation

• 08800049201657 - DIO Open Wrench: 2023-09-18
• 08800049302330 - DIO Ratchet Wrench: 2023-09-18
• 08800049304129 - DIO Square Wrench: 2023-09-18
• 08800049306109 - DIO Torque Wrench: 2023-09-18
• 08800049251409 - UF(II) Scan Adapter: 2023-09-11
• 08800049430569 - UF(II) Eco Base Abutment: 2023-09-11
• 08800049430576 - UF(II) Eco Base Abutment: 2023-09-11
• 08800049430583 - UF(II) Eco Base Abutment: 2023-09-11