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Written by Dr. Michael Fleming
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Wednesday, 09 December 2009 17:15 |
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Aug. 4, 2009, marked the date the Food and Drug Administration released its long-awaited regulation on dental amalgam. The 116-page Final Rule will take effect Nov. 4, 2009, and is titled, “Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy.” In addition, the FDA has published a guidance document titled, “Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.”
The Final Rule formally classifies the encapsulated amalgam into Class II, reclassifies dental mercury into Class II, and designates special controls to accompany the classification changes. The entire Final Rule and Special Controls document is available for review on FDA’s Web site.1 I encourage a careful reading of these documents.
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Written by Dr. Michael Fleming
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Tuesday, 25 August 2009 18:30 |
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Health professionals enjoy a very high level of confidence among consumers. Studies indicate your dentist is one of the most trusted of health care providers. However, there may be occasions when you will want to secure a second opinion. This is especially true if you feel uncertain about the treatment being proposed. There are a number of very good reasons you may wish to seek additional advice and counsel before entering into what could be expensive, and perhaps even unnecessary dental treatment.
Today’s consumer of dental services is more informed and educated than at any time in the history of the profession. The demand for cosmetic and re-constructive dental procedures has skyrocketed in recent years. At the same time, the technology required to deliver these services has and continues to be introduced at a rapid pace. While these advances in dentistry are exciting and desirable, they often come with a high price tag, both to the dentist and the patient. |
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Written by Dr. Michael Fleming
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Tuesday, 25 August 2009 18:28 |
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Are dental amalgams bad for your health? The debate continues to rage about the mixed-metal tooth fillings, which contain mercury and other potentially toxic substances. The topic is of particular interest to people with CFIDS, who are searching for relief from the multitude of symptoms they face every day.
The American Dental Association (ADA) states unequivocally that amalgam fillings are safe, since the mercury is made stable when mixed with other materials. Although other materials are now available for fillings, the ADA says that amalgams still play a role in modern dentistry — and should not be removed simply out of unfounded concern over the presence of mercury.
Yet not all medical professionals are convinced. Michael Fleming, DDS, writes that amalgam removal cannot promise miracles — but should not be completely rejected, either. |
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Written by Dr. Michael Fleming
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Tuesday, 25 August 2009 18:20 |
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Dr. Fleming was recently honored to be appointed to a four year term as a Consultant to the Center for Devices and Radiologic Health of the Food and Drug Administration. His tasks include advising FDA on matters related to the safety and effectiveness of medical devices to include dental products. Dr. Fleming is the former Consumer Representative on the Dental Products Panel of the Food and Drug Administration (FDA). He has also served as the Acting Consumer Representative on the Circulatory System Devices Panel that advises FDA on matters related to products and devices utilized within the heart and blood vessels.*
Dr. Fleming’s new role as a Consultant requires him to periodically interface with the FDA and other designated stakeholders with respect to medical device review and regulation. His specific role as a Consultant or panel member is to impartially and objectively evaluate scientific data, clinical trial designs, risk assessments and other matters brought before an advisory panel to enhance FDA’s regulatory decision making process.
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Written by Dr. Michael Fleming
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Friday, 16 February 2007 00:00 |
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There is likely not one reader of this publication who is unaware of the ongoing controversy surrounding the use of dental amalgam. The dental profession continues to debate the safety and effectiveness of a material that has served dentistry’s restorative needs for the better part of two centuries. However, consumer and regulatory pressure to eliminate mercury-containing products from dentistry, medicine, and the environment is at an all-time high. This makes it an entirely appropriate time to talk frankly about an issue that has too long plagued the profession.
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