Healing Abutment Anatomical

GUDID 00810044842043

OSSEOFUSE INTERNATIONAL, INC.

Dental implant abutment analog, laboratory

• Primary Device ID: 00810044842043
• NIH Device Record Key: 3a2526fc-d8aa-4913-b91b-f6e80fa2c676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healing Abutment Anatomical
• Version Model Number: HPHAA4507M
• 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	00810044842043 [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

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

Moist Heat or Steam Sterilization

[00810044842043]

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 Anatomical]

• 00810044842135: HPHAA7507M
• 00810044842128: HPHAA7505M
• 00810044842111: HPHAA7503M
• 00810044842104: HPHAA6507M
• 00810044842098: HPHAA6505M
• 00810044842081: HPHAA6503M
• 00810044842074: HPHAA5207M
• 00810044842067: HPHAA5205M
• 00810044842050: HPHAA5203M
• 00810044842043: HPHAA4507M
• 00810044842036: HPHAA4505M
• 00810044842029: HPHAA4503M
• 00810044842012: HPHAA3707M
• 00810044842005: HPHAA3705M
• 00810044841992: HPHAA3703M