Author Archives: Udell Dental Lab

New Federal 2.3% Medical Device Excise Tax


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.


Chinese herb may provide relief for autoimmune disorders

 BOSTON, Mass., USA: Researchers from the Harvard School of Medicine have discovered that a chemical compound found in a traditional Chinese root extract affects autoimmunity by preventing a harmful class of immune cells from developing.

Dichroa febrifuga, commonly known as chang shan, is one of the 50 fundamental herbs of traditional Chinese medicine and has been used as a malarial agent for more than 2,000 years. In the course of a study, Malcolm Whitman, Professor of Developmental Biology at Harvard School of Medicine, and his colleagues found that halofuginone (HF), a natural quinazolinone alkaloid occurring in the herb could be used to treat autoimmune disorders.

Their findings about the small-molecule compound could also be relevant for dental autoimmune immune disorders, such as chronic ulcerative stomatitis. U.S. researchers found in 2011 that painful oral lesions associated with the disease are most likely caused by an autoimmune response.

Earlier studies conducted by Whitman’s team in 2009 had already demonstrated that HF activates a response pathway that blocks the development of harmful T helper 17 cells (Th17), which play a key role in autoimmune diseases such as multiple sclerosis and rheumatoid arthritis, and that in this regard HF is very selective in its effect. A series of experiments demonstrated that HF inhibits the development of Th17 cells, but does not affect other kinds of T-cells involved in regular immune function.

HF acts by triggering a biochemical pathway known as amino-acid starvation response (ARR), which typically prevents cells from forming when amino acids are in short supply. By depleting amino acids, researchers were able to induce ARR and inhibit differentiation of Th17 cells.

In the current study, Whitman’s research team investigated how HF activates the AAR pathway by looking at the most basic process that cells use to translate DNA into the amino-acid chain that makes up a protein. Experiments demonstrated that HF targets a particular enzyme that incorporates the amino acid proline into proteins. It was observed that whenever proline was in short supply, ARR kicked in and produced the therapeutic effects of HF treatment.

According to Whitman, “This compound could inspire novel therapeutic approaches to a variety of autoimmune disorders.”

With regard to the treatment of autoimmune disorders, the challenge has been suppressing inflammatory attacks by the immune system on body tissue without generally suppressing immune function. In instances of chronic ulcerative stomatitis, treatment was only successful using hydroxychloroquine, a prescription drug primarily used to prevent malaria and rheumatoid arthritis.

“This study is an existing example of how solving the molecular mechanism of traditional herbal medicine can lead both to new insights into physiological regulation and to novel approaches to the treatment of diseases,” said Tracy Kelly, an instructor in Whitman’s lab.

However, researchers do not yet fully understand the role that amino-acid limitation plays in disease response or why restricting proline inhibits Th17 cell production.


Mobile dentistry clinic aims to put smiles on more local children’s faces


A new $320,000 bus is helping Walnut Street Community Health Center in downtown Hagerstown expand its dental care services to more children in the community, health center Executive Director Kim Murdaugh said Monday.

U.S. Sen. Ben Cardin, D-Md., attended a ribbon cutting for the 39 1/2-foot-long bus outside the downtown Hagerstown clinic on Monday morning.
The bus is “critically important for access to dental care for our children,” Cardin said.

Clinic officials wanted the bus, which will make stops at schools, to do more than just provide dental cleanings and sealants, which help prevent cavities but don’t address tooth decay, Murdaugh said.

The bus’ dental staff can address immediate needs such as fillings and extractions, the latter as long as the child will be able to return to the classroom, clinic officials said. An appointment at the clinic can be scheduled for more involved work.

Before the bus, clinic officials who visited schools were limited to talking about dental and nutritional health and handing out toothbrushes and toothpaste, clinic officials said.

The clinic started using the bus in November 2011, visiting Head Start programs in the Hagerstown area, said Dr. Ilaya Rajagopal, a pediatric dentist and dental director for the clinic.

By the end of February, the bus will begin visiting Washington County Public Schools, clinic officials said. First up will be Hickory, Lincolnshire, Winter Street, Salem Avenue, and Eastern elementary schools first on the list, said Connie Richardson, office manager for the clinic’s dental practice. Those schools are Title I schools, which means they have higher populations of students from low-income families.

Parents must complete a consent form for children to be treated on the bus, Murdaugh said. If a dental emergency arises, the staff might try to contact parents so they can treat the child immediately, she said.

The 24 N. Walnut St. clinic has had a pediatric dental practice since it opened nine years ago, and expanded the dental practice to serve adults during its third year, Murdaugh said. The clinic is between North Walnut and North Prospect streets.

The clinic serves the insured and uninsured as well as people with Medicare or Medicaid, Murdaugh said. The uninsured pay based on a sliding scale that factors in their income and the number of people in the household, she said.

About 75 percent of the 6,500 people the health center serves have no insurance or Medicaid, Murdaugh said.

The clinic has approximately 2,300 dental patients, of whom about 1,800 are children, clinic officials said.

Money from the United Way of Washington County covers dental services for people, especially children, who cannot afford to pay, Murdaugh said.

Sens. Cardin and Barbara Mikulski, D-Md., supported the health center’s request for American Recovery and Reinvestment Act funds for the bus, Cardin said.

The Maryland Community Health Resource Commission provided $98,000 for the first two years of operating costs for the bus, Murdaugh said. That enabled the clinic to hire a fourth dentist, Dr. Mark Kawczynski, who will work on the bus, clinic officials said.

The bus will be used to target dental needs of children, however its customer base might be extended to adults in the summer when school is out, Murdaugh said.

Richardson said the bus will operate three days a week at first.

The bus’ six-person dental staff, including the dentist, attended an RV boot camp to learn to drive the bus, Richardson said.


Preventing Bacteria from Falling in With the Wrong Crowd Could Help Stop Gum Disease

Stripping some mouth bacteria of their access key to gangs of other pathogenic oral bacteria could help prevent gum disease and tooth loss. The study, published in the journal Microbiology suggests that this bacterial access key could be a drug target for people who are at high risk of developing gum disease.

Oral bacteria called Treponema denticola frequently gang up in communities with other pathogenic oral bacteria to produce destructive dental plaque. This plaque, made up of bacteria, saliva and food debris, is a major cause of bleeding gums and gum disease. Later in life this can lead to periodontitis and loss of teeth. It is this interaction between different oral pathogens that is thought to be crucial to the development of periodontal disease.

Researchers from the University of Bristol have discovered that a molecule on the surface of Treponema called CTLP acts as the key pass that grants the bacterium access to the community, by allowing it to latch onto other oral bacteria. Once incorporated, CTLP in conjunction with other bacterial molecules can start to wreak havoc by inhibiting blood clotting (leading to continued bleeding of the gums) and causing tissue destruction.

Professor Howard Jenkinson, who led the study, said that periodontal disease and bleeding gums are common ailments, affecting many groups of people, including the elderly, pregnant women and diabetics. “Devising new means to control these infections requires deeper understanding of the microbes involved, their interactions, and how they are able to become incorporated into dental plaque,” he said.

The study shows that CTLP could be a good target from which novel therapies could be developed. “CTLP gives Treponema access to other periodontal communities, allowing the bacteria to grow and survive. Inhibiting CTLP would deny Treponema access to the bacterial communities responsible for dental plaque, which in turn would reduce bleeding gums and slow down the onset of periodontal disease and tooth loss.” The team is now working to find a compound that will inhibit CTLP. “If a drug could be developed to target this factor, it could be used in people who are at higher risk from developing gum disease,” explained Professor Jenkinson.

The latest study backs up previous work in Professor Jenkinson’s lab on the workings of harmful oral bacteria. “The overarching message from our latest study as well as previous work is that regular tooth brushing and maintaining a healthy mouth is vitally important to keep harmful mouth bacteria at bay,” he stressed.


UK cosmetologist sentenced for illegal tooth whitening


TORQUAY, UK: A cosmetologist from Torquay has been successfully prosecuted for offering tooth-whitening treatment illegally. Carl Espano, who pleaded guilty to practising dentistry although not registered with the General Dental Council (GDC), has been ordered to pay a fine of £1,872.


According to a report by, Torquay has been fined £1,000 and ordered to pay a £15 victim surcharge. Furthermore, the cosmetologist has been ordered to pay full costs to the GDC of £857.

Espano, in mitigation of his actions, raised the House of Lords’ judgement in the case of “Optident and Another v. Secretary of State for Trade and Industry and Another [2001] UKHL 32”. However, the magistrates appeared to give this argument little or no weight when determining his sentence.

“This is a serious offence, particularly for potential victims, as you did not have any indemnity in place for any damage you might have done to any teeth,” the Magistrates told Espano. “In addition, should you have damaged the adult teeth, a patient only has one set. Accordingly we view this as a serious offence.”

Chief Executive and Registrar of the GDC, Evlynne Gilvarry, said: “We are committed to taking action against people who offer tooth whitening unlawfully. They are a risk to the people they treat and it is our duty act to ensure public safety.”

In the UK, tooth whitening is the practice of dentistry and can only be offered by those registered with the GDC.


Oral bacteria linked to risk of pneumonia


RUGBY, UK/NEW HAVEN, USA: Changes in bacteria in the mouth precede the development of pneumonia, researchers from Yale University’s School of Medicine have found. Previous studies have shown a higher pneumonia mortality rate in people with an above average number of gum problems.


For the study, 37 participants were examined over the course of a month by study leader Dr Samit Joshi and his team. The subjects included 19 healthy adults with an average age of 60 and those at risk of health care-associated pneumonia, including ten nursing home residents (average age of 86) and eight mechanically ventilated ICU patients (average age of 51). The researchers found that patients on ventilators who contracted pneumonia had experienced a significant change in their oral bacteria prior to falling ill.

“Our findings may improve the way we prevent pneumonia in the future by maintaining the bacteria that live within our mouths,” Joshi said.

Respiratory illnesses and oral health have been long associated because bacterial infections in the chest are believed to be caused by breathing droplets from the mouth and throat into the lungs.

Pneumonia affects over 620,000 people in the UK alone and claims the lives of around five per cent of those who contract the disease.

The findings of the study present further evidence that oral bacteria pose a significant health risk to the elderly and the young, according to Dr Nigel Carter, Chief Executive of the British Dental Health Foundation based in Rugby, UK.

“Systemic links between gum disease and overall health have been well documented, and at this time of year keeping up good oral health can really help stave off illness,” Carter stated. “Simply brushing your teeth for two minutes twice a day using a fluoride toothpaste, cleaning in between teeth daily with interdental brushes or floss, cutting down on how often you have sugary foods and drinks and visiting the dentist regularly, as often as they recommend will be a great starting point. If you have swollen gums that bleed regularly when brushing, bad breath, loose teeth or regular mouth infections appear, it is likely you have gum disease.”

Carter suggests seeing a dentist or dental practitioner immediately, if any of these symptoms persist, or signs of pneumonia develop.


Dental students practise on corpses


DUNDEE, UK: Dental students at the University of Dundee have become the first in the UK to practise their surgical dental skills on cadavers. The university has adopted the Thiel embalming technique, which retains many of the tissue properties of the living body than those embalmed according to the conventional method.


The cadavers the Dundee students practise on are donated for the purposes of teaching, training and research and are used not only by dentistry students, but also by researchers at the university’s Institute of Academic Anaesthesia, who use the embalmed bodies to examine the effects of anaesthetics administered with the aid of ultrasound imaging.

A pilot project with third-year students in the School of Dentistry has just been carried out successfully, and thus Thiel cadavers will be used more widely for dentistry teaching.

“The Thiel bodies give us an excellent and very lifelike way of training dentists before they have live patients,” Dr Christine Hanson, project leader and Associate Specialist in Oral Surgery at Dundee.

According to Hanson, using simulators, mannequins or even animal heads, students do not develop the kind of transferable skills they can when working on a human body.

“It is a fantastic opportunity for our students. We hope to explore a range of procedures, including the placing of dental implants, and I am convinced this will give them the sort of hands-on experience that we have never been able to offer before,” Hanson said.

The university, which is the first in the UK to use Thiel embalming exclusively, has launched the Million For A Morgue fundraising campaign to build a new morgue to support this method. The university itself has committed £1 million to the project. The campaign has attracted the support of leading crime writers, including Val McDermid, Lee Child, Tess Gerritsen and Kathy Reichs.