OsseoFuse Ball Analog

GUDID 00810044841411

OSSEOFUSE INTERNATIONAL, INC.

Dental implant analog

• Primary Device ID: 00810044841411
• NIH Device Record Key: ee203c53-fd05-49a5-bf1f-05fd07df12b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsseoFuse Ball Analog
• Version Model Number: CLBA
• Company DUNS: 080694564
• Company Name: OSSEOFUSE INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00810044841411 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

[00810044841411]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-02
• Device Publish Date: 2025-11-24

Devices Manufactured by OSSEOFUSE INTERNATIONAL, INC.

• 00810044841459 - Round Bur one size length: 2025-12-03
• 00810044841466 - HexaPLUS S OneDrill Implant System: 2025-12-03
• 00810044842623 - HexaPLUS Dental Implant: 2025-12-03
• 00810044842630 - HexaPLUS Dental Implant: 2025-12-03
• 00810044842678 - HexaPLUS Dental Implant: 2025-12-03
• 00810044842685 - HexaPLUS Dental Implant: 2025-12-03
• 00810044842692 - HexaPLUS Dental Implant: 2025-12-03
• 00810044842708 - HexaPLUS Dental Implant: 2025-12-03