HexaPLUS Dental Implant

GUDID 00810044842692

OSSEOFUSE INTERNATIONAL, INC.

Dental prosthesis/implant abutment screw analog, single-use

• Primary Device ID: 00810044842692
• NIH Device Record Key: d35a13cd-932b-4006-aa3f-0cd2f5eea3a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HexaPLUS Dental Implant
• Version Model Number: HLCT
• 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	00810044842692 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

[00810044842692]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-03
• Device Publish Date: 2025-11-25

On-Brand Devices [HexaPLUS Dental Implant]

• 00810044842715: HLBA
• 00810044842708: HLOT
• 00810044842692: HLCT
• 00810044842685: HLIA
• 00810044842678: HLAR
• 00810044842630: HLIC
• 00810044842623: HLCC