Tag Archives: Dental Imports

What Is In Your Mouth? The Issues…


Understand the importance of choosing a Certified Dental Laboratory (CDL) for high quality dental restorations.

The ability of dentists to deliver a high standard of care in restorative and cosmetic dentistry is enhanced by working with a laboratory that has undergone 3rd party certification. Working with a Certified Dental Lab will assure that your restorations are manufactured by or under the guidance of Certified Dental Technicians. Certification is a voluntary process, and is the dentist’s added assurance that the lab is committed to providing quality products and services that comply with regulatory requirements for material quality and traceability.

Poorly-made dental restorations – whether made in America or abroad – can lead to a range of health consequences for patients, and in turn, legal consequences for dentists. To ensure better outcomes for safe dental restorations, it is extremely important that dentists and patients have a full understanding of where their dental restorations are coming from and what materials are used in the process.

In the USA, domestic dental laboratories remain unregulated in more than 40 states. Some companies call themselves domestic dental laboratories, and receive prescriptions shipped from dentists all across the US, but in reality they produce nothing, but serve as a front for companies producing outside the USA.

Dental restorations increasingly are being imported from countries like China, India and Vietnam. Depending on the country, those dental laboratories may not be subject to the same scrutiny that domestic laboratories receive from the U.S. Food and Drug Administration.

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New Federal 2.3% Medical Device Excise Tax

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Considerations for U.S. Dentists and U.S. Dental Laboratories in Light of Increased Regulation

The new 2.3% Medical Device Tax will have certain beneficial effects on the dental industry both in the U.S. and abroad.

Domestically, it will reinforce the requirement of using FDA registered materials in medical devices, by requiring the foreign manufacturer and importer to provide documented proof of material composition and provenance. It is also an important next step toward global quality regulation of medical devices, already well established in many markets, through ISO quality standards and U.S. FDA regulation.

The low prices offered by foreign labs with lower operating costs are challenging the U.S. dental lab industry. With the new Medical Device Tax, the increased cost of regulating and importing medical products may help to balance the playing field. U.S. dentists may re-evaluate the benefits of choosing a full-service domestic dental laboratory, and using highly skilled U.S. technicians.

Defining the “Taxable Medical Device” under the 2.3% tax law

The IRS looked to the FDA for definition of a “taxable medical device”, and the key is FDA registration. All manufacturers, producers, and importers of medical devices must register with the FDA and submit a list of the medical devices that they manufacture, produce, or import. All “listed” devices are subject to the new 2.3% tax.

All imported dental devices are required to be listed. Each type of imported restoration receives a product code, and is taxable under the law.

Whoever imports as the initial owner of the device, whether it is a dental laboratory or a dentist, is responsible for paying the tax.

Dental laboratories are generally exempt from registering with the FDA, unless they import devices from foreign labs. With the exception of sleep apnea devices and snore guards, most domestically made crowns, bridges, dentures, veneers and retainers will not be subject to the tax. However, many materials and components used by dental labs will be taxable as medical devices.

The Dentist and Laboratory Relationship

In all countries, dentists benefit from working with full service local laboratories. They often know the technicians by name, the level of their skill, and can expect consistent quality work. They also know the quality of the materials used, and can rely on clear communication for difficult combination cases.

In the U.S. particularly, domestic laboratories are required to have an established quality management system in place to provide the required material and process control, and confidential patient history with full traceability for every case. U.S. labs are also subject to audit at any time to assure regulatory compliance.

Dental restorations are patient-specific medical prosthetic devices. With such a direct patient interface, dental restorations should not be marketed as a commodity. Until such time that global quality regulation is practicable, there will be measureable benefits for the dentist who works with the local dental laboratory.