"Committed to providing the highest quality crowns, bridges and implants, SCDL is Australia's only truly global dental laboratory, with worldwide locations that now includes our new Sydney laboratory and Melbourne office."

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Quality & Safety

The fundamental philosophy used to build our company is through a process, not a person.

Every technician employed at SCDL's manufacturing partner, Modern Dental Laboratory, must attend the technician school (located within the laboratory). These programs, from beginner right through to our advanced courses are the cornerstone of the laboratory because this is where the patient-centric culture is instilled and adherence to highly specific manufacturing processes is engendered.

These specific manufacturing regulations are administered by the ISO 13485:2003, ISO 9001:2008.  By meticulously abiding by these stringent regulations, we are able to continually produce consistent products which can be monitored and reviewed at every stage of manufacture.

Again, it's not the person fabricating the restoration, it's the process.

No other lab can provide you with the level of quality assurance that we can.

  • All materials used are listed on the Australian Register of Therapeutic Goods (TGA)

  • ISO 13485:2003 International standard in Quality Management of Medical Device Certificate

  • ISO 9001:2008 Generic Quality Management System

  • Verifiable quality materials using the Identalloy and IdentCeram systems

  • Research and Development

  • SCDL : Expert Dentist Panel oversees the total process

  • 5-15 year warranty to both dentist and patient

 

Inclusion on the Australian Register of Therapeutic Goods (TGA register)

Materials used  in the manufacture and fabrication of our devices can be found on the Australian Register of Therapeutic Goods under our company name  Pavona Pty Ltd ( who owns 100% of Southern Cross Dental Laboratories)

About the ARTG

The publically accessible version of the Australian Register of Therapeutic Goods (ARTG) is the reference database of the Therapeutic Goods Administration (TGA). It provides information on  therapeutic goods that can be supplied in Australia. Sponsors of materials, medicines and devices entered on the ARTG have demonstrated to the TGA that their product's benefits outweigh the risks for their intended use.
The ARTG is available online for anyone to view. Information you can find on the ARTG includes:

  • Product name and ingredients

  • Sponsor and manufacturer details ( we are listed under Pavona Pty Ltd) 

  • If a material  is registered or listed

  • Class level for medical devices.

Samples of our ARTG certification as awarded to Pavona Pty Ltd which trades as Southern Cross Dental Laboratories

ISO certification

ISO certification is recognised as the only true global standard  for verification of quality in both manufacturing process and materials used in dental laboratories.

The certification is extremely difficult to gain and to maintain as audits are conducted by specialist companies on an annual basis. Very few laboratories attain this level of certification.

Why is ISO certification important to YOU?

Third party certification is a proven method to meet or exceed voluntary industry standards.

ISO certified organizations are therefore likely to meet or exceed the consumers' standards. The ISO specifications provide a clear-cut process for improving documentation in every facet of operations including:

  • Dental prescriptions/work authorizations;

  • Patient contact materials;

  • Subcontractor/supplier agreements;

  • Material and equipment purchases;

  • Employee training and continuing education;

  • Maintenance and calibration of equipment;

  • Correct  labelling;

  • Material traceability;

  • Trouble shooting

A certified ISO lab can provide documentation in compliance of regulatory procedures in the event of a lawsuit.

 

ISO History

ISO is the acronym for International Organization for Standardization. ISO is a network of the national standards institutes of 157 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. Because "International Organization for Standardization" would have different abbreviations in different languages ("IOS" in English, "OIN" in French for Organisation Internationale de Normalisation), it was decided at the outset to use a word derived from the Greek "isos", meaning "equal." Therefore, whatever the country, whatever the language, the short form of the organization's name is always ISO.

International standardization began in the electro-technical field: the International Electro-technical Commission (IEC) was established in 1906. Pioneering work in other fields was carried out by the International Federation of the National Standardizing Associations (ISA), which was set up in 1926. The emphasis within ISA was laid heavily on mechanical engineering. ISA's activities came to an end in 1942. In 1946, delegates from 25 countries met in London and decided to create a new international organization, of which the object would be "to facilitate the international coordination and unification of industrial standards." The new organization, ISO, officially began operations on 23 February 1947.

Between 1947 and the present day, ISO published more than 16,000 International Standards. More than half a million organizations in more 149 countries are implementing ISO 9000 which provides a framework for quality management throughout the processes of producing and delivering products and services for the customer.

ISO 9000 is concerned with "quality management." This means what the organization does to enhance customer satisfaction by meeting customer and applicable regulatory requirements and to continually improve its performance in this regard. Our lab completed initial registration in ISO 9001 in 1997.

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

We are proud to include below the certification for ISO 13485:2003

 

ISO 13485:2003

What is ISO 13485:2003?

The ISO 13485:2003 certificate is the international standard in quality management for medical device manufacturing, and is the most rigid global standard in manufacturing, exceeding even those of the FDA. Obtaining this level of certification is the key to eliminate variability in our processes so that our dentists always get consistent output.

Why ISO 13485:2003?

The requirements for each certification are based on the ability to demonstrate compliance to standards by documentation, adherence to written processes, internal and external quality management, and material traceability record keeping. This is a detailed and disciplined process and often an onerous task, but it helps sharpen an organization into an efficient quality driven machine.

 

 

ISO 9001:2008

What is ISO 9001:2008?

"The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out products that satisfy customers' expectations."

An accredited ISO  lab can provide documentation in compliance of regulatory procedures in the event of a lawsuit.

Please refer to the current certification for our manufacturing partner, Modern Dental Laboratory,

 

Verifiable quality materials using IdentAlloy and IdentCeram systems

Internationally recognised, IdentAlloy and IdentCeram certificates identify the company, brand and composition of the alloy or porcelain  in a particular restoration.

SCDL provides a certificate with each case that you should attach to your patient records to verify the materials at any juncture. The corresponding section is kept in our laboratory for further verification if required.

With this information, labs and dentists gain a proven, practical way to document and communicate the quality not only of the materials they use but also their own commitment to the highest professional standards.

IdentAlloy


IdentCeram


Visit www.identalloy.org for more information

 

5 to 15 year warranty on crown and bridgework

We are so confident in the quality of our materials and manufacturing processes, we offer a written 5 to 15 year guarantee on most of our crown and bridge products and a one year guarantee on our removable prostheses. Please refer to our website for the terms and conditions of this warranty.

A guarantee for your patient is now available upon request for your patient. Please ring our customer service team.

Guarantee Card - Dental Laboratory

Expert Panel

SCDL have assembled an unrivalled team of internationally renowned experts who act both in an advisory capacity to clinicians and technicians and with our research and development team to improve clinical efficacy. No other labs offer a service of this nature or quality. Please refer to our list of experts in the attached documents.

Please click here for more details.

 

Research and development

SCDL are one of very few dental laboratories which invests heavily in research and development. We are proud to bring many new products to the market and our team of dentists and technicians continually challenges conventional thinking in order to raise the quality of clinical performance.

Penn Composite Stent developed exclusively by Dr David Penn and SCDL

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