*Note: not all products listed on the MDL, Hong Kong site are available in the U.S.
Quality & Safety
The fundamental philosophy used to build our company is through a process, not a person. Every technician employed by Modern Dental Laboratory must attend our technician school (located within our laboratory). These beginning and advanced courses are the backbone of the lab because this is where the patient-centric culture is instilled and adherence to very specific manufacturing processes it taught.
These specific manufacturing regulations are administered by the ISO 13485:2003, ISO 9001:2008 and EN 46002. By meticulously abiding by these stringent regulations, we are able to continually produce consistent products.
Again, it’s not the person fabricating the restoration, it’s the process.
ISO 13485:2003 International standard in Quality Management of Medical Device Certificate
ISO 9001:2008 Generic Quality Management System
EN 46002 EU Implantable Medical Device Directives
CDL/CDT Certified Dental Laboratory/Technician
- ISO History
- ISO 13485:2003
- ISO 9001:2008
- Q's & A's: A brochure for open communication with your patients.
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 electrotechnical field: the International Electrotechnical 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 continually to improve its performance in this regard. Our lab completed 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 announce our registration for ISO 13485:2003 and click to see our certificate.
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 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, it is hard work, but it helps sharpen an organization into an efficient quality driven machine.
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 product that satisfies customers’ expectations."
Why is ISO certification important to YOU?
Third party certification is a proven method to meet or exceed voluntary industry standards. Those 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; maintenance and calibration of equipment; labeling; customer complaints; and material traceability. A certified lab can provide documentation in compliance of regulatory procedures in the event of a lawsuit.
What is a CDL?
The Certified Dental Laboratory (CDL) provides assurance that a laboratory has met specific standards relating to quality assurance, safety, and business and manufacturing practices. By earning and maintaining the CDL designation, a dental laboratory is always monitoring and attempting to improve the quality and efficiency of their services and facilities.
Why is a CDL important?
Certification in the dental laboratory profession is voluntary. Laboratories who have taken the extra steps to become certified represent the top of their field. CDLs have documented not only compliance with peer-defined standards but a desire to stay in the forefront of the industry.
Who recognizes a CDL?
The CDL is recognized by the National Association of Dental Laboratories (NADL), the American Dental Association (ADA) and the American College of Prosthodontists (ACP).
- Heikas CDT Ceramics
- Heikas CDT Crown and Bridge
- John Li CDT Complete Dentures
- Julian CDT
- Ramzy CDT
- John A. CDT
- John A. CDT Technologist
- CDL (Chicago Service Center)
- CDL (LA Service Center)
- CDL (Seattle Service Center)
The FDA recognizes ISO 13485:2003 as exceeding its own Good Manufacturing Practices (GMP).
The FDA is the federal regulatory body for medical device manufacturers, of which dental labs are included. They require all domestic and import manufacturers to comply with the GMPs. The only third party method of certifying that these GMPs are part of a dental lab manufacturing practice is the ISO 13485:2003.
Boston Service Center FDA # 3009163037
Chicago Service Center FDA # 3003358121
Los Angeles Service Center FDA # 3006988076
Seattle Service Center FDA # 3004016005
Q's & A's
Modern Dental Laboratory USA has compiled a list of common Questions and Answers that will help you communicate with your patients regarding their restorations.
Question: "How do I know the products will be made with superb quality?"
Answer: Be assured that the products used by Modern Dental Laboratory USA are inspected at the highest level of strict guidelines by world-known and respected organizations.
MDL USA is ISO 13485 Certified: The rigorous standards are designed to help companies create and maintain specific procedures necessary to produce quality products and services. ISO 13485 certified companies must undergo external audits to ensure ISO standards are maintained. ISO 13485 Certification is your guarantee that Modern Dental Laboratory USA has documented quality procedures and systems in place that meet global standards and expectations. No U.S. dental lab has attempted to undertake the necessary steps to prove their quality.
MDL USA is FDA Registered: The FDA ensures that all products are accurately and informatively represented to the public. Imported products that do not measure up to the FDA standards are not allowed on the U.S. market.
Question: "My crown was made in China? Does it have any lead?"
Answer: No, you will not find lead, nickel, beryllium or any other harmful elements in our products.
In over 30 years, our lab has grown to over 2,000 technicians and has earned its place among the top labs in the world. We've accomplished this by delivering consistently high quality raw materials which produce consistently high quality products.
These superior materials come from top European companies such as Ivoclar, Dentsply and Bego. These world known products are then shipped to our laboratory in Hong Kong for fabrication.
Question: "The Chinese are not trained like our technicians. Do they know how to make teeth?"
Answer: Yes, the Chinese are the best people in the world to create your restoration because:
- Our Chinese laboratory has a long history (over 30 years) in producing large quantities of intricate products of superb quality and inexpensive prices while still maintaining the ISO and FDA regulations.
- Our lab is also set up as a learning institution allowing our technicians to learn and improve their skills in order to keep up with the demands of modern dentistry.
- Not only do the Chinese have a history in porcelain (inventors of porcelain and "china"), but they are also known for their ornate motor skills that are expressed in an array of miniature artworks.
Question: "Isn't outsourcing bad for our economy? We are putting US techs out of work?"
Answer: The negative impact of outsourcing on the economy and American employment has been greatly exaggerated and the benefits of outsourcing almost entirely ignored.
Myth: Outsourcing is a one-way street.
Fact: Outsourcing works both ways.
The number of jobs coming from other countries to the U.S. (jobs "insourced") is growing at a faster rate than jobs moved to overseas. According to the Organization for International Investment, the numbers of manufacturing jobs insourced to the United States grew by 82 percent, while the number outsourced overseas grew by only 23 percent.
Myth: A job outsourced is a job lost.
Fact: Outsourcing means efficiency.
Outsourcing is a means of achieving greater final output with lower financial input, which leads to lower prices for all U.S. firms and families. Lower prices lead directly to higher standards of living and more jobs in a growing economy.
Myth: U.S. manufacturing jobs are moving to poor nations, especially China.
Fact: Nations are losing manufacturing jobs worldwide, including China.
U.S. manufacturing employment declined 11% between 1995 and 2002, which is identical to the average world-wide decline. China has seen a sharper decline, losing 15% of its industrial jobs over the same period.
Question: "Are imported teeth from China cheap because they don't have any regulations?"
Answer: We can offer you world-class regulated restorations at affordable prices!
Cheap?: Imported teeth from China are inexpensive because the cost of labor is lower. Sixty percent of the cost to fabricate teeth is labor; therefore, we are able to spend up to 6 times the duration it takes a local technician to build a crown. Not only are you saving money, but the end result is a more beautifully crafted crown that seats quickly into your patients' mouths.
Regulated?: Our lab is much more regulated than a domestic lab. In order to meet the demands of our European clients, we became ISO certified in 1997. The ISO certification surpasses all FDA requirements. Also, we are scrutinized at the border by both Customs and the FDA. There is no U.S. laboratory that can exceed or even meet the same regulations and guidelines that Modern Dental Laboratory USA has met.