Quality and Safety - Southern Cross Dental Laboratories

Your guarantee of
Quality and Safety
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“The world’s leading dental laboratory”

Smile !
Feel confident, Feel safe
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Congratulations !
Your dentist has most likely given you
this brochure to ensure that you are
fully informed about who is making your
prosthesis, whether it is a crown, bridge,
implant, veneer, denture or simple
mouthguard or bleaching tray. The fact
that your dentist has chosen one of
the world’s leading dental laboratories
(one of only a handful with our level of
internationally recognised accreditations)
to make your device should make you
feel supremely confident that you are in
safe and experienced hands.
Southern Cross Dental Laboratories
(SCDL) is one of the largest in the world
and supplies dentists in many countries.
Our principal source of manufacturing
is in Shenzen in China where we have
assembled one of the most famous,
globally acclaimed, state of the art dental
laboratories in the world. We also have
smaller boutique manufacturing facilities in
Sydney, Australia and Tampa, USA which
are aimed at supporting our main production
facility for research and development.
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Quality & Safety
No other lab can provide you with the
level of quality assurance that we can.
The fundamental philosophy used to build our
company is through a process, not a person.
Every technician employed by Southern
Cross Dental Laboratories (SCDL) and
its’ manufacturing partner, Modern Dental
Laboratory, must attend our technician school
(located within our laboratory).
These programs, from beginner right through
to our advanced courses are the cornerstone
of our laboratory because this is where the patientcentric
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 to these stringent
regulations, we are able to continually produce
consistent products which can be monitored
and reviewed at every stage of manufacture.
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SCDL
World Leaders in Quality
and Safety Assurance
• 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
• Expert Dentist Panel oversees the total process.
• 5-15 year warranty to both dentist and patient
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Inclusion on the
Australian Register
of Therapeutic Goods
(TGA register)
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.
Materials used in the manufacture and fabrication of
our devices can be found on the Register under the
company name: Pavona Pty Ltd (who owns 100%
of Southern Cross Dental Laboratories).
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
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Samples of our ARTG certification
Australian Register of Therapeutic Goods Certificate
Issued to
Pavona Pty Ltd
for approval to supply
Pavona Pty Ltd - Dental ceramic
ARTG Identifier
188459 Class IIa
ARTG Start date 23/08/2011
Product Category:
Medical Device Included Class IIa
GMDN 16187
GMDN Term
Dental ceramic
Intended Purpose
This is a ceramic-based material (porcelain) used in prefabricated dental
restorations such as inlays, artificial teeth, metal-ceramic crowns, or
bridges.
Manufacturer Details Address Certificate number(s)
Ivoclar Vivadent AG Bendererstrasse 2
DV-2011-MC-11021-3
Schaan
LIECHTENSTEIN, , FL-9494
Liechtenstein
ARTG Standard Conditions
The above Medical Device Included Class IIa has been entered on the Register subject to the
following conditions:
· The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are
as specified in section 41FN of the Therapeutic Goods Act 1989.
· The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989
when kinds of medical devices are included in the Register are as set out in the following paragraphs.
· For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor
must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be
identified.
· Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in
the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III
medical device, or Class IIb medical device that is an implantable medical device, the distribution
records shall be retained for a minimum period of 10 years. In the case of records relating to any other
device, the distribution records shall be retained for a minimum period of 5 years.
· The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log
of information of the kind specified in Regulation 5.8.
· It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III
or implantable Class IIb provides three consecutive annual reports to the Head of the Office of Devices,
Blood and Tissues, Therapeutic Goods Administration following inclusion of the device in the ARTG.
(as specified in 5.8 of the regulations) Annual reports are due on 1 October each year. Reports should
be for the period 1 July to 30 June. The first report following the date of inclusion in the ARTG must be
for a period of at least six months but no longer than 18 months. Subsequent reports are to be provided
on 1 October for a further 2 years. The annual report must include all complaints received by the
manufacturer relating to problems with the use of the device that have been received by them over the
year.
· Where a medical device included in the Register, contains a substance which is included in the Fourth
Schedule to the Customs (Prohibited Imports) Regulations or the Eighth Schedule to the Customs
(Prohibited Exports) Regulations the Sponsor shall, at the time of importation or exportation of the
medical device, be in possession of a licence and a permission for importation or exportation of each
consignment of the goods as required by those regulations.
· A sponsor shall ensure that a medical device within their control is stored and transported in
accordance with the instructions and information provided by the manufacturer.
Australian Register of Therapeutic Goods Certificate
Issued to
Pavona Pty Ltd
for approval to supply
Pavona Pty Ltd - Dental alloy, casting, non-noble
ARTG Identifier
188460 Class IIa
ARTG Start date 23/08/2011
Product Category:
Medical Device Included Class IIa
GMDN 35857
GMDN Term
Dental alloy, casting, non-noble
Intended Purpose
This is a casting alloy suitable for the fabrication of dental restorations
and appliances.
Manufacturer Details Address Certificate number(s)
Ivoclar Vivadent AG Bendererstrasse 2
DV-2011-MC-11021-3
Schaan
LIECHTENSTEIN, , FL-9494
Liechtenstein
ARTG Standard Conditions
The above Medical Device Included Class IIa has been entered on the Register subject to the
following conditions:
· The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are
as specified in section 41FN of the Therapeutic Goods Act 1989.
· The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989
when kinds of medical devices are included in the Register are as set out in the following paragraphs.
· For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor
must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be
identified.
· Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in
the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III
medical device, or Class IIb medical device that is an implantable medical device, the distribution
records shall be retained for a minimum period of 10 years. In the case of records relating to any other
device, the distribution records shall be retained for a minimum period of 5 years.
· The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log
of information of the kind specified in Regulation 5.8.
· It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III
or implantable Class IIb provides three consecutive annual reports to the Head of the Office of Devices,
Blood and Tissues, Therapeutic Goods Administration following inclusion of the device in the ARTG.
(as specified in 5.8 of the regulations) Annual reports are due on 1 October each year. Reports should
be for the period 1 July to 30 June. The first report following the date of inclusion in the ARTG must be
for a period of at least six months but no longer than 18 months. Subsequent reports are to be provided
on 1 October for a further 2 years. The annual report must include all complaints received by the
manufacturer relating to problems with the use of the device that have been received by them over the
year.
· Where a medical device included in the Register, contains a substance which is included in the Fourth
Schedule to the Customs (Prohibited Imports) Regulations or the Eighth Schedule to the Customs
(Prohibited Exports) Regulations the Sponsor shall, at the time of importation or exportation of the
medical device, be in possession of a licence and a permission for importation or exportation of each
consignment of the goods as required by those regulations.
· A sponsor shall ensure that a medical device within their control is stored and transported in
accordance with the instructions and information provided by the manufacturer.
Products covered by this Entry
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ISO accreditation
ISO accreditation is recognised as the only true
global standard for verification of quality in both
manufacturing process and materials used in dental
laboratories. The accreditation 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 accreditation.
Why is ISO certification important to YOU ?
Third party accreditation is a proven method to
meet or exceed voluntary industry standards and is
ideal for dental labs.
ISO accredited 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 the
making of your prosthesis including:
Dental prescriptions/work authorizations
Patient contact materials
Material and equipment purchases;
Employee training and continuing education
Maintenance and calibration of equipment
Correct labelling
Material traceability
Trouble shooting
An accredited ISO lab can provide documentation
in compliance of regulatory procedures in the event
of a lawsuit.
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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.
International standardization began in the electrotechnical
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.
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ISO History continued...
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.
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ISO 13485:2003
What is ISO 13485:2003 ?
The ISO 13485:2003 certificate is the
international standard in quality management for
medical and dental 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 results for their patients.
Why ISO 13485:2003 ?
The requirements for each certification are
based on 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.
Please refer to the current certification for our
manufacturing partner, Modern Dental Laboratory.
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We are proud to include our
registration for ISO 13485:2003
and ISO 9001:2008 below.
(Modern Dental Laboratory is the
manufacturing partner of SCDL).
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Verifiable quality materials using
IdentAlloy &
IdentCeram systems
Internationally recognised, IdentAlloy and
IdentCeram certificates identify the company, brand
and composition of the alloy or porcelain in a
particular restoration that is going in your mouth.
SCDL provides a certificate with each case that is
attached to your 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 for their patients.
IdentAlloy
IdentCeram
Visit www.identalloy.org for more information
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5 to 15 year warranty on
crown and bridgework
SCDL are so confident
in the quality of our
materials and manufacturing
processes, we offer to
our dentists and patients
a written 5 to 15 year
guarantee on most of our
crown and bridge products
and a one year guarantee on
our removable prostheses.
The guarantee for your
work is generally kept by your dentist with your
records. Please confirm this with your dentist when
your restoration has been inserted or completed.
Research & 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
challenge conventional
thinking in order to raise
the quality of clinical
performance.
Your dentist is kept fully
informed about these
developments and will be
able to offer you cutting
edge procedures and
choice of restorations.
The Penn Composite Stent
was developed exclusively
by Dr David Penn & SCDL.
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Expert Panel
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SCDL have assembled an unrivalled team of
SCDL ‘ASk the expert’ pAneL
internationally renowned experts who act both in
an advisory If you would capacity like a second to opinion clinicians about a patient and or seek technicians
further
information about materials or case selection, simply log on to our
and with website our and research navigate to “Ask and the Expert”. development We have assembled a team to
world class team of highly qualified dentists and technicians who
improve clinical will respond efficacy. to your query within 48 hours.
You can attach images or x-rays to aid in diagnosis.
Dr David penn
Dr David Penn graduated from Sydney University in 1978 and has been in
private practice ever since. He founded SCDL in 1983 and has built it into one
of the largest and most sophisticated laboratories in the world with offices in
the USA, UK, Ireland, NZ, Hong Kong and Australia. David has published many
articles and lectures on aesthetics, Invisalign and crown and bridgework. He
graduated as MBA in 2006 from Rushmore University and in 2007, created the
philosophy of Anterior Aesthetic Alignment. In 2008, he completed writing the
AAA / Invisalign accreditation course and released the Penn Composite Stent.
Dr David reaney
Dr Reaney graduated from The University of Edinburgh with a Bachelor of
Dental Surgery degree with distinction in Prosthetics and Conservative Dentistry
in 1985. In 1993 he received his Diploma in General Dental Practice from the
Royal College of Surgeons – London and graduated Master of Clinical Dentistry
in Fixed and Removable Prosthodontics in 2003. He previously combined clinical
practice with the academic post of Clinical Lecturer in the School of Dentistry,
Royal Victoria Hospital, Belfast providing teaching and training to undergraduate
dental students. He is managing director of Southern Cross Dental Laboratories (Ireland).
Associate professor Jack Gerschman
Associate Professor Jack A. Gerschman is the Associate Professor, (Dental
Services) The Alfred Hospital and Respiratory Sleep Department, Monash
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Associate Professor Gerschman completed his Ph.D investigating chronic
**2010 version 6:Layout 1 4/8/10 Orofacial 12:40 PM pain Page syndromes, 1 particularly non responsive, protracted TMD
conditions. He has a wide array of expertise including temporomandibular
disorders, craniofacial syndromes, chronic and acute facial pain syndromes
SCDL ‘ASk the expert’ pAneL
and orofacial trauma.
Dr ray McLendon
Dr Ray McLendon (Orthodontist) largest and most experienced Invisalign®
provider in the USA, former Vice President of Education, Align Technology.
Dr McLendon is the owner of six privately held orthodontic practices in the
Houston area which is the largest orthodontic group and the US’s leading
Invisalign Practice.
Dr Albert Sharp
Dr Albert Sharp won the NSW Dental Board scholarship prize for
academic performance in 1998 before graduating at Sydney University with
First Class honours and top of the year. He sat on the Recent graduates
committee of the ADA NSW in 2002/03 and joined Dr David Penn in 2003
as an associate. Albert joined Southern Cross Dental Laboratories as a clinical
and technical advisor and became a partner in the Double Bay dental practice.
Albert has made a significant contribution to the development of the AAA
philosophy in 2008.
Dr Michael Stubbs
Dr Michael Stubbs is a specialist in oral medicine. He is a member of both the
American Academy of Dental Sleep Medicine and Australasian Oro-Facial Pain
Academy and a specialist consultant at the Alfred Hospital.
He is also Visiting Lecturer for the Bachelor of Oral Health Program, School of
Dental Science at the University of Melbourne and Contributing Editor of the
Australian Dentist magazine.
peter Williams
Peter Williams qualified in the UK as a City of Guilds Dental Technician
and worked in the UK and South Africa where he ran own ceramics
No other labs offer dental laboratories a before service relocating to Australia this in 1998. Peter nature has since or
qualified as a Dental Prosthetist and has worked in health and private
quality. Please refer practices as a Ceramist. to our He brings list with him of a wide experts range of experience in the
across all aspects of dental technology with a specific interest in removable
prosthetics and ceramics.
attached documents and rest assured that they
are available to your dentist to ensure world class
quality outcomes for you.
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Need help ?
or wish to know more ?
Visit us at
www.scdlab.com
Email: australia@scdlab.com
Phone: (02) 9362-1177
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“The world’s leading dental laboratory”