Sleep Apnea Device IFU

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

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

Contraindication

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 the use of positive airway pressure could exacerbate.

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 and 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 appliance is crafted to cover the upper and lower teeth and stays secure through adaptable metallic connectors. You may engage the device by means of adjustable lugs or by the Herbst® mechanism, which is a rod and tube assembly that orients the jaws in a predetermined relationship. Place the upper piece of the appliance in the patient’s mouth and have the patient 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 appliances. The adjustment mechanisms are designed for the doctor to advance the mandible to the desired position incrementally.  Dorsal is a two-piece design with separate upper and lower acrylic portions that, when engaged, propel the mandible into a 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. Finding the most comfortable and effective position may require some trial and error.
  • 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 is advised to use the device according to the guidelines provided by your practice, which may encompass detailed instructions regarding the daily duration of wear and the appropriate times for removal.

Adjustment recommendations

  • Operate the bur at high speed, applying minimal pressure while using water.
    • It's important to maintain the temperature using water and air spray. This method helps prevent the formation of micro-fractures. A fine-grit diamond is advisable for adjustments, and air-only handpiece adjustments are not recommended.
    • For shaping different surfaces, specific tools are best:
      •  A football-shaped bur is effective for the occlusal and lingual surfaces, especially on anterior teeth 
      • A tapered bur is better suited for the buccal and lingual surfaces.

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. The manufacturer advises against immersing the device in solutions, which could lead to delamination.

Storage instructions

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

Additional Information

  • Clinical studies on sleep apnea devices have shown that they 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.

Insurance Apnea Codes

Apnea Codes
Medical Codes:
Herbst/ Dorsal E0486 Oral device/ appliance used to reduce upper airway collapsibility, adjustable or non-adjustable, custom fabricated, includes fitting and adjustment
Dental Codes:
Herbst/ Dorsal D9947 Custom sleep appliance fabrication and placement
Herbst/ Dorsal D9948 Adjustment of custom sleep apnea appliance
Herbst/ Dorsal D9949 Repair of custom sleep appliance
CPT home sleep study:
Herbst/ Dorsal 95800 Sleep study, unattended, simultaneous recording; heart rate, oxygen saturation, respiratory analysis (e.g., by airflow or peripheral arterial tone), and sleep time.
Herbst/ Dorsal 95801 Sleep study unattended w/ respiratory analysis.
Herbst/ Dorsal 95806 Sleep study, unattended, simultaneous heart rate recording, oxygen saturation, respiratory airflow, and respiratory effort.
G Home Sleep Study codes:
Herbst/ Dorsal G0398 Sleep study, w/ type II portable monitor; unattended; minimum of 7 channels: EEG, EOG, EMG, ECG/heart rate, airflow, respiratory effort, and oxygen saturation.
Herbst/ Dorsal G0399 Sleep study w/ type III portable monitor; unattended; minimum of 4 channels: 2 respiratory movement/airflow, 1 ECG/heart rate, and one oxygen saturation.
Herbst/ Dorsal G0400 Sleep study w/ type IV portable monitor; unattended; minimum of 3 channels.
Herbst: FDA and Medicare Approval: Both Dandy Herbst and Dorsal have 510(k) clearance and Class II FDA approval. 
Premarket Submission Number: K103076
Registered Establishment Number: 1937100
Regulation Number: 872.5570
Product Code: LRK
Dorsal: FDA and Medicare Approval: Both Dandy Herbst and Dorsal have 510(k) clearance and Class II FDA approval. 
Premarket Submission Number: K103076
Registered Establishment Number: 1937100
Regulation Number: 872.5570
Product Code: LRK

Material Safety Data Sheets (MSDS)

Other Dandy Dental Device Material Safety Data Sheets (MSDS): attached are the safety data sheets for various dental materials such as Herbst, Dorsal, surgical guides, and models.

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