Did you know that some dental crowns or “caps” may have lead in them? Well, its true. A dentist usually has the small pieces of dental work made in the laboratory. While most labs can make the dental work on premises, sometimes they “outsource” their crowns to other countries such as China. These outsourced labs may not have the same quality control standards as labs in the Unites States. In other words, sometimes there may in lead in your crowns and other dental work.
The American Dental Association has provided the following questions and suggestions for due diligence about making your dental work:
o Do you outsource any part of my work to other labs?
o If yes, specifically what work of mine is outsourced?
o Do you outsource any part of my work to a foreign lab?
o If yes, will you provide me with the FDA registration number of foreign lab doing my work?
o Will you also provide me with your registration number with the FDA as an “initial importer,” “re-packager” or “re-labeler?”
o Have you actually visited the foreign lab to which you are outsourcing my work?
o Will you provide me with documentation that the materials used in the work you outsource are FDA approved and compliant with all ANSI and ISO standards?
o Will you fill my detailed lab prescription as written, regardless of where my work is fabricated?
o Will you provide me with a document detailing the materials used in my work?
o Will you provide me with a written indemnification and assume all liability arising from claims for injuries allegedly caused by dental restorations coming from your lab that may contain adulterated or toxic materials?
Your dental laboratory should be able to answer each of these questions to your complete satisfaction.
Reasoning behind the questions:
o Some labs outsource domestically, as well as internationally.
o Most of the outsourcing to foreign labs is crown and bridge.
o Foreign outsourcing is still a relatively small share of the market, estimated to be approximately 15-20%.
o A foreign lab importing to the US must be registered with the FDA.
o Domestic labs that import, re-package or re-label must also register with the FDA.
o A site visit may imply a higher level of “due diligence” by the domestic partner.
o Labs should stand behind the material content of the outsourced work.
o Dentists should be as specific as possible, designating components and brands in their prescriptions. Labs should fill dental prescriptions exactly as written, and inform dentists in advance of any substituted materials.
o Labs should be able to provide you with detailed written statement of assurance.
o Labs that are confident in the materials they use should not be hesitant to stand behind their work with an indemnification.
Finally, I would ask your dentist for the certification of ingredients. Your dentist can ask the laboratory that they use, for the certificate of ingredients. By having the certificate, you can ensure the health of your tooth. You can also tell if there were toxic materials used in making your tooth.