Fabrication of Oral Appliances

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:  
                        1. Safety
                        2. Performance - does it do what it is supposed to do?
                        3. Effectiveness- is a significant target portion clinically successful?
All oral appliances are mandated to be available by prescription only, not OTC

NB: MANY MANUFACTURERS WILL TELL YOU THAT THE APPLIANCE IS FDA ACCEPTED FOR THE TREATMENT OF OSA AND THE 510 K LIMITS ACCEPTANCE TO THE TREATMENT OF MILD, OR MILD-MODERATE OSA ONLY !!!!!!!!!

GET COPIES OF THE 510 K’s!!!!!!

OTHERS WILL SAY THE APPLIANCE IS FDA ACCEPTED AND NOT SAY THAT IT IS FOR SNORING ONLY!!!!

 

Click a photograph to review details about an appliance
and see large image.

 

Appliance Accepted
for
Tx Snoring 		 Accepted
for
Tx OSA		  510 K SINGLE
click
on IMAGES
Adjustable
Soft Palate Lifter 		 X      
A.M.E. Tongue Retaining Device   X      
Breathe EZ X   K022891  
Dental-Anti Snoring X      
DESRA  X      
Elastomeric
(EMA)		     K946112
EMA T X   K973884  
Goldilocks
(SAGA)		 X    
LSWD  X   K062333
H&M Anti-Snoring Device  X      
Nose Breathe     K013687
Silensor   X      
Snoring Control Device X      
Snorefree  X   K955336
Snore Guard X   K882303 SnoreGard
Snoremaster  X      
Snore-No-More X      
Snorex  X      
Snore-X X      
Snoretec X      
Snore Peace  X      
Snore-Cure  X      
Snore-Ezzer  X      
Somnoguard 2.0 X   K061688
Therasnore  X      
Adjustable Therasnore* X      
EMA* X X K971794
EMA Titratable* X X    
Equalizer    X    
Full Breath Sleep Appliance X X K053065 K053065
Herbst Appliance*  X X K955822  
Hilsen Adjustable  X   K963591
Klearway*     X X K950763  
MDSA*  X X
K042161
Nocturnal Airway Patency Appliance   (NAPA) X X K902790
OPAP    X K991926  
OASYS*
(also a nasal dilator)		 X X K030440
OSAP
(sic) 		 X X K960673
PM Positioner*
 X X K955503
PM Positioner*
(Non-adjustable) 		X X K953293  
Quiet Night        X K032410  
Respironics Custom Oral Appliance X X K033822  
Restful Nights 1st  X x K021569/ S3  
Silencer*      X ? K 954530  
Silentnite   X X K991926
Silent Partner   X X K051014  
Sleep and Nocturnal Obstruction
Patency Appliance
(SNOAR)		 X X    
Sleep Splint  X X K060122  
Snore hook Discluder   X X K041184  
Somnomed MAS X X K050592
Somnoguard adjustable  X   K061688
SUAD* X X K023836
TOA
(Thornton Oral Appliance)		 X X TAP 1:
K964516 TAP T:
 K061732		  
Tap Anti-snoring Device  X   K972061
Tongue Locking Device  X      
Snore-Aid* Plus   ? X K991449  
Tongue Stabilizer  X   K993381  
                                                                                                                   
All photos as well as text used with large photos seen in this section, courtesy of www.Quietsleep.com

Denist1

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/