Frequently Asked Questions

In 2014, we received FDA clearance for our mRNA appliance® for the treatment of snoring and mild to moderate obstructive sleep apnea. Our FDA 510(k) number is K130067. The mRNA appliance® is a part of the DNA appliance® system, which is also registered with the FDA.
Pneumopedics® is the process of non-surgical airway remodeling that may result from treatment with the DNA appliance® system. The pair of images below shows a comparison of a person's airway before and after Pneumopedic® treatment with a DNA appliance® system. Note that results will vary for individual cases. Airway Before and After treatment with the DNA appliance™ System.
Epigenetics is a booming field of research, which shows that the outcomes of growth and development (phenotypes) can be changed without altering the underlying genes. There are numerous ways of producing these epigenetic (gene-environmental) interactions, including changes in nutrition, but we mostly use biomimetic oral appliance therapy. Biomimetics is a science that studies natural models and then uses these designs and processes to solve human problems.
Craniofacial epigenetics uses a person’s natural genes to correct and develop the jaws, teeth, soft tissues and functional spaces, painlessly, using biomimetic appliances. Our biomimetic oral appliances aim to mimic natural growth and development - even in adults by harnessing a person’s genetic potential.
Dr Dave Singh defines genetic potential as the capacity to produce an optimized outcome in the prevailing conditions, subject to a viable population(s) of stem cells.
Epigenetic orthodontics uses a person's natural genes to correct and straighten the teeth without the use of force brackets.
Yes, but only in the sense that the human genome is implicated during pneumopedic, orthopedic and/or orthodontic treatments, and that certain biomimetic oral appliances or devices, such as the DNA appliance® or mRNA appliance® can upregulate or modulate gene expression during pneumopedic, orthopedic and/or orthodontic treatments. However, no gene-modification, artificial genes or gene-transfer is used at all. Only a person’s naturally-occurring genes are implicated in Dr Singh's Epigenetic concepts. In other words, our biomimetic oral appliances are involved in a system that has been specially-designed solely by Dr Singh to bioengineer facial, skeletal, dental and airway structures so that natural developmental processes are evoked by our pneumopedic/orthopedic/orthodontic devices, such as the DNA appliance® or mRNA appliance® to enhance the teeth, jaws, TMJ, face and airway into more optimal relations for functions, such as sleep and breathing.
Research shows that changes in the spatial relations of the jaws invokes activation of various genes. In other words, when the position of the jaws is changed using a device, the genes respond to that change. So, using a new generation of biomimetic oral appliances, which can be worn similar to regular oral appliances and orthodontic retainers, dentists and orthodontists can enhance airway, facial, dental and TMJ health. Some evidence for these ideas is already available in the medical, dental and orthodontic literature. The DNA appliance® system does not rely on lifetime wear unlike mandibular advancement devices and continuous force exerted by conventional orthodontic braces. But they help to guide the teeth, jaws, TMJ, face and airway into more optimal relations for functions, such as sleep and breathing. Specifically, DNA appliances consist of patented 3-D Axial springs™ that are specially made from DNA wire™ which requires careful, periodic adjustments by the dental professional.
Epigenetic orthodontics means that various human genes or combinations of (the) a patient's naturally-inherited genes are harnessed in combination or independently with various orthodontic, orthopedic and/or pneumopedic® devices or DNA appliances® to modify, change or attenuate the physical location of natural teeth, jaws and the upper airway in 3-D space during orthodontic, orthopedic and/or pneumopedic® treatments, based on the concept of 'temporo-spatial patterning.' The term "temporo-spatial patterning" like Global Positioning Satellite (GPS) implies that the spatial organization of the teeth, jaws and airway can be mapped in 3-D space at known anatomical locations using x, y, z coordinates. The pattern in 3-D space of craniofacial structures are encoded within the patient's genome. Dr Singh believes that DNA appliances® are capable of modulating genetic pathways, which are effectively dormant or inactive, and are capable of restarting craniofacial development in adult patients as well as in children. In addition, abnormal patterning is corrected, in part, through the deployment of orthodontic, orthopedic and/or pneumopedic® devices or DNA appliances® , which may evoke natural developmental processes that improve a patient's upper airway and thereby ameliorate or prevent airway issues such as snoring and other forms of sleep-disordered breathing such as sleep apnea through non-surgical airway remodeling™.
Traditionally, specially-trained orthodontists use fixed braces to apply forces to straighten crooked teeth. While many of these cases are initially treated successfully, it is known that relapse can occur after treatment. Relapse means that a patient's teeth will move back after treatment has been completed. The reasons for relapse are complex and remain incompletely understood. However, the entire human genome has now been sequenced, and we now know that certain genes are involved in moving teeth. Teeth are naturally-designed to move, for example, tooth eruption in a normally-growing child. In addition, the teeth in some people erupt in a specific arrangement, producing a beautiful smile. Dr Singh teaches that the specific arrangement of teeth is due to certain genes. In fact, a natural process called 'temporo-spatial patterning' is at work. This process is the blueprint or body plan that is encoded by genes. In other words, the right and left sides of the body, the top and bottom of the body as well as the front and back of the entire body is under the control of a genetic body plan, including the teeth. Sometimes, however, the plan gets disturbed, producing crooked teeth, for example. The DNA appliance® system is used to address these issues.
The DNA appliance® System is manufactured worldwide in: United States, Canada, Australia, India, Japan, Malaysia, South Korea and Taiwan. For a complete list of all of the current labs with their contact information, please vist our labs page here: DNA Appliance® System Certified Laboratories.
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