Working with us

Compliance

Here at Southern Cross Dental, you can be assured of our safety, compliance and quality. We work hard to provide the utmost in quality and compliance, to give you and your patients peace of mind.

Safe. Compliant. Responsible

In Australia, most dental laboratory products are categorised as a ‘medical device’ for regulatory purposes. This means that the manufacture, export and supply is regulated by the Therapeutic Goods Administration (TGA).

We adhere to the highest levels of quality management to ensure that our products are made in compliance with all government regulations. The safety and reliability of our products sets the standard for high-quality dental products.

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We don’t just follow best industry practice – we set best industry practice

Our materials

At Southern Cross Dental, we source all our raw materials and components from internally evaluated and approved internationally reputable suppliers: Ivoclar Vivadent, Dental Direkt, Argen and Asiga, to name a few.

All product critical materials are listed on the Australian Register of Therapeutic Goods, managed by ourselves or the Australian sponsor. This standard is maintained by our quality processes.

If you would like to see data sheets or more information for any of our materials, please get in touch. Our systems ensure identification and traceability from purchase, through manufacture, all the way to sale.

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Transparent procedures are our priority

Here at Southern Cross Dental, we meet the regulatory obligations set by the Therapeutic Goods Administration (TGA). The TGA was established to ‘safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods’. The product portfolio contains classified Patient-Matched Devices. This means:

Stage 1- Complete

The TGA has been notified of all patient matched medical devices that we produce, as part of the transition phase.

All cases are manufactured on instruction from an authorised health professional.

Stage 2- In Progress

All products registered with the TGA are manufactured under “ISO 13485 – Medical Devices – Quality Management System” accredited by a third party notified body.

Infection control practices

More than ever, it is so important to provide clean and safe practices, and we operate stringent decontamination procedures at Southern Cross Dental. This means that all cases are processed on arrival at our facilities, and returned to you with confidence. Our Standard Range production facilities have received ISO 13485:2016 for medical device manufacturing. All products are sanitized with FDA-approved disinfectants.

Our Australian sites operate under an Infection Control Management Plan that is compliant with Dental Board of Australia, Australian Dental Association Guidelines and Australian/New Zealand Standards.

In our Standard Range, product manufacture is also governed by protocols aligned with The Guideline for Disinfection and Sterilization in Healthcare Facilities (Centre for Disease Control, 2008).

Interested to see our infection control practices? Watch here.

Contact us for more information about our best industry practice for safety and compliance.