B. Gail Denko, DMD PC, Dental Sleep Medicine. Specializing in the treatment of patients with snoring and obstructive sleep apnea.
“Anyone can escape into sleep, we are all geniuses when we dream, the butcher's the poet's equal there.”
Emile M. Ciora
Oral Appliance Therapy
The job of the FDA is to protect consumers and make sure that the benefits of a product outweigh the risks. Their committee on medical devices determined at a meeting in the fall of 1997 that for purposes of treatment, snoring and OSA are considered medical diseases and that all oral appliances for tx of these 'diseases' fall under FDA aegis. The following appliances {class 2} were granted premarket Notification / 510K acceptance which means that they were found to be substantially equivalent to devices marketed before May 28, 1976 and thus allowed to be marketed under the general controls of the Federal Food, Drug and Cosmetic Act rather than requiring specific FDA approval. Appliances which are new in concept {Class 3}, with no prior similar device require Premarket Approval (PMA) by the FDA where submission of full statistical scientific data is required.
The FDA assures:
* Safety
* Performance - does it do what it is supposed to do?
* Effectiveness- is a significant target portion clinically successful?
The FDA accepts OAs ONLY for use in people over 18 years of age.
All oral appliances are mandated to be available by prescription only, not OTC
MANUFACTURERS WILL OFTEN SAY THE APPLIANCE IS FDA ACCEPTED AND NOT SAY THAT IT IS FOR SNORING ONLY!!!
FOR MORE INFORMATION CLICK HERE!
Dentists play an important role in the team approach to the treatment of obstructive sleep apnea.
Physicians, dentists, psychologists, and respiratory therapists all pool their knowledge to treat each patient appropriately and effectively.
Dentists who are specifically trained in aspects of sleep medicine and have a command of multiple appliance modalities are of great help to physicians in treating patients with sleep disordered breathing problems.
AVALABLE OFFICE HOURS:
9:00 t o 5:00 (Mon)
9:00 to 5:00 (Wed–Sat)
12:00 to5:00 (Sun)
CALL 617.964.4028
in Massachusetts
317.842.9866
in Indiana
The National Center on Sleep Disorders Research, can provide you with sleep education materials. As well as publications on heart, lung and blood research:
Two Rockledge Center, Suite 7024, 6701Rockledge Drive, MSC 7920, Betesda, MD 20892-7920
(P)301.435.0199 /
(F) 301.480.3451
www.nhlbi.nih.gov/about/ncsdr/
Information about sleep disorders may be obtained from NHLBI:
NHLBI Information Center
P. O. Box 30105, Bethesda, MD 20824-0105
(P) 301.251.1222 / (F) 301.251.122
www.nhlbi.nih.gov/