Healing Abutment Standard

GUDID 00810044841978

OSSEOFUSE INTERNATIONAL, INC.

Dental implant abutment analog, laboratory

• Primary Device ID: 00810044841978
• NIH Device Record Key: 0fb92372-5feb-4973-b922-4a43965f1052
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Abutment Standard
• Version Model Number: HPHAS7505M
• Company DUNS: 080694564
• Company Name: OSSEOFUSE INTERNATIONAL, INC.
• 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	00810044841978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243078

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

Moist Heat or Steam Sterilization

[00810044841978]

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

On-Brand Devices [Healing Abutment Standard]

• 00810044841985: HPHAS7507M
• 00810044841978: HPHAS7505M
• 00810044841961: HPHAS7503M
• 00810044841954: HPHAS6507M
• 00810044841947: HPHAS6505M
• 00810044841930: HPHAS6503M
• 00810044841923: HPHAS5207M
• 00810044841916: HPHAS5205M
• 00810044841909: HPHAS5203M
• 00810044841893: HPHAS4507M
• 00810044841886: HPHAS4505M
• 00810044841879: HPHAS4503M
• 00810044841862: HPHAS3707M
• 00810044841855: HPHAS3705M
• 00810044841848: HPHAS3703M