Sleep Apnea Device IFU


Sleep Apnea


Description of Device

A Dandy sleep apnea device is a type of dental device used to treat snoring and mild to moderate obstructive sleep apnea. It is also known as a mandibular advancement device or mandibular repositioning device.

Indications for Use - Sleep Apnea

Dandy devices are custom-made to fit your mouth and are designed to be as comfortable and unobtrusive as possible.


Sleep apnea devices may not be appropriate for individuals with severe respiratory conditions, such as severe chronic obstructive pulmonary disease (COPD), severe asthma, or other conditions that could be exacerbated by the use of positive airway pressure.


Oral devices, which are used to treat sleep apnea by repositioning the jaw and tongue, may not be suitable for individuals with severe dental issues, such as untreated gum disease or extensive tooth decay. Similarly, individuals with severe jaw problems or temporomandibular joint (TMJ) disorders may require careful evaluation to determine if an oral appliance is appropriate.

Potential Risks & Benefits of sleep devices, Advise Patients of the Following:

The primary benefit of a sleep apnea device is its ability to correct malocclusion and related jaw discrepancies. It is common for patients to experience some initial discomfort or soreness when the appliance is first placed or adjusted. This discomfort usually subsides as the patient adapts to the device.

Directions for Use

To ensure proper use of the devices, follow these steps:

  • Before inserting the sleep apnea device, brush and floss the teeth and rinse the mouth with water to ensure good oral hygiene and prevent any food particles from getting trapped under the device.
  • The device is designed to fit over the upper and lower teeth and is held in place by adjustable metal connectors. You may engage the device by means of adjustable lugs, or by the Herbst® mechanism, which is a rod and tube assembly that orientates the jaws in a predetermined relationship. Place the upper piece of the appliance in the patient’s mouth and have them bite down gently to position it properly.
  • The Herbst® is a one piece construction held together by two adjustment mechanisms on the buccal or outer area of the upper and lower appliance. The adjustment mechanisms are designed for the doctor to incrementally advance the mandible to the desired position.  Dorsal is a two-piece design with separate upper and lower acrylic portions that when engaged posture the mandible into protrusive position via acrylic fins built in the lower acrylic portion. 
  • The Dorsal is an adjustable design utilizing advancement; once the upper piece is in place, insert the lower piece of the device and then adjust the metal connectors to hold the lower jaw in a slightly advanced position. This may require some trial and error to find the most comfortable and effective position.
  • The patient should breathe through their nose and ensure that the appliance is properly seated and comfortable. It may take some time to adjust to the feeling of the appliance in the mouth, but most patients find that they can sleep comfortably with it in place.
  • The patient should wear the device  as directed by your practice, which may include specific instructions on how long to wear it each day and when to remove it.

Cleaning instructions:

Dandy recommends cleaning your sleep apnea device daily before and after every use. Immediately after removal, use warm water (not to exceed 45°C/113°F) and soap to remove remaining saliva and debris from the device.

Storage instructions:

Use a case specifically designed for dental devices to protect from contamination and damage. The case should have good airflow to prevent moisture buildup.

Additional Information:

  • Clinical studies on sleep apnea devices have been shown to effectively correct malocclusion by promoting forward movement of the lower jaw and improving skeletal alignment. They contribute to improved dental and facial aesthetics and can reduce the need for permanent tooth extractions.
  • If the patient experiences any adverse events, such as pain or irritation, they should discontinue use and contact your practice immediately.
  • Sleep apnea devices come with a limited warranty, which may vary depending on the manufacturer.
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