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Introduction

Dental devices make up a huge market in the US and the rest of the world. The size of the global market for dental devices was pegged at around $4.5 b for 2011. Dental devices are generally used for dental prosthesis like dentures. They are also used tosupportsoft and hard tissues surrounding the oral cavity, whichhas to be custom made for every individual to replace missing teeth.Dental devices also include dental chairs, hand pieces, CAD/CAM systems, scaling units, instrument delivery systems, dental lasers, intra oral and extra oral radiology equipment, and CBCT scanners.

Outsourcing is the process of contracting a business function, previously performed in-house, to an external provider. From feasibility study to design, research to development, prototype to production and everything in between can be outsourced. One of the major reasons for outsourcing is to focus on core business but in reality the focus has shifted to cost savings.

Concerns Ignorance

There is a growing concern is that dentists and their patients may be using outsourced products without even being aware of it. Such ignorance can often lead to the use of substandard products that can adversely affect the health of Americans.

Dental offices often send work order to the closest dental work laboratory, known for quality. Some of these laboratories outsource the work to overseas and restrict themselves to administrative duties. The imported product is checked by their skeleton staff for quality and minor adjustments are undertaken in-house.  After relabeling and repackaging, the dental prosthesisfinally ends up at the dental offices.

Cost vs Quality

Dental prosthesisis often outsourced due to low cost of the overseas product. They are cheaper by 33 to 50% than comparable American dental prosthesis. Dentists often use outsourced dental prosthesison patients who negotiate for a better price and on those who do not have any dental insurance. New dentists are also known to use outsourced dental prosthesis, when they first start their practice, for financial reasons. The quality including material and fixture of the outsourced dental prosthesis is likely to degrade to harmful levels as cost becomes the only criteria for outsourced products.

Lead Poisoning

One of the major concerns is the presence of lead in outsourced dental prosthesis. Lead is a hazardous substance for adults and has serious health risks for growing youngsters. Lead poisoning is often not discovered until irreversible damage has taken place and is usually due to exposure from swallowing or breathing lead particles.

Regulations

The Food and Drug Administration (FDA) requires laboratories, which outsource dental work to overseas, to give information related to outsourcing to the dentists. In reality, dentists obtainsuch information only upon request and the obtained information is usually not passed to the patient as it is not mandatory.

The FDA also oversees imported medical devices or devices that are relabeled, repackaged or manufactured. All medical devices with problems need to be reported but adverse reactions surrounding medical devices are rarely reported.

Therefore, the National Association for Dental Laboratories (NADL) is concerned about the public’s safety and wants all laboratories dealing with dental work to:

·         Register with a state agency

·         Have at least one Certified Dental Technician (CDT)

·         Use FDA approved materials

·         Disclose materials used in dental prosthesis

·         Disclose the point of origin of manufacture