Osteon Medical

GUDID D102SGKBE20

Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.

IMPLANT SOLUTIONS PTY LTD

Dental implant abutment analog, scanning

• Primary Device ID: D102SGKBE20
• NIH Device Record Key: 9bba936c-afde-4473-87bd-9fe5ed4906bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteon Medical
• Version Model Number: 1
• Company DUNS: 756242111
• Company Name: IMPLANT SOLUTIONS PTY LTD
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com
• Phone: +61392640111
• Email: info@osteonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D102SGKBE20 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

[D102SGKBE20]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-19
• Device Publish Date: 2023-09-11

On-Brand Devices [Osteon Medical]

• D102SCANGAUGEKIT0: Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition
• D102BRIDGE0: The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in th
• D102BAR0: The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in th
• D102SGKAA20: Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition
• D102SGKBE20: Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition
• D102SGKBG20: Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition
• D102SGKBF20: Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition