Overview: This article provides instructions for the use, maintenance, and clinical considerations for Dandy Herbst and Dorsal sleep apnea devices. It includes safety information, step-by-step application guides, and regulatory codes for dental practices.
Device Overview
A Dandy sleep apnea device is a custom dental appliance used to treat snoring and mild to moderate obstructive sleep apnea. These devices, also known as mandibular advancement devices, work by repositioning the jaw and tongue to keep the airway open during sleep.
Contraindications for Use
Sleep apnea devices may not be appropriate for individuals with the following conditions:
Severe Respiratory Conditions: Including severe chronic obstructive pulmonary disease (COPD) or severe asthma.
Dental Issues: Untreated gum disease or extensive tooth decay.
Jaw Disorders: Severe temporomandibular joint (TMJ) disorders.
Directions for Device Insertion
Follow these steps to ensure the sleep apnea device is seated correctly:
Clean Mouth: Have the patient brush and floss their teeth before insertion.
Seat Upper Appliance: Place the upper piece of the appliance in the patient’s mouth and have the patient bite down gently to position it.
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Engage Lower Appliance: * For Herbst devices, the rod and tube assembly will orient the jaws.
For Dorsal devices, insert the lower piece after the upper is in place, then adjust the metal connectors.
Verify Comfort: Ensure the patient can breathe through their nose and that the device is comfortable.
Adjustment Recommendations for Clinicians
When adjusting the device, use the following technical standards:
Equipment: Use a high-speed handpiece with water and air spray to prevent micro-fractures in the material.
Bur Selection: Use a fine-grit diamond bur. Use a football-shaped bur for occlusal and lingual surfaces; use a tapered bur for buccal surfaces.
Pressure: Apply minimal pressure during adjustments.
Cleaning and Storage Instructions
To maintain the integrity of the sleep apnea device, follow these hygiene protocols:
Daily Cleaning: Clean the sleep apnea device daily before and after every use.
Washing: Use soap and warm water (not exceeding 45°C/113°F).
Avoid Immersion: Do not immerse the device in cleaning solutions for extended periods, as this may cause delamination.
Storage: Store the device in a dedicated dental case with proper 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 and Medical Coding
The following codes apply to the fabrication and adjustment of Herbst and Dorsal devices:
| 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)
Regulatory and Material Safety
Both Dandy Herbst and Dorsal devices have 510(k) clearance and Class II FDA approval (Premarket Submission Number: K103076). For detailed material information, refer to the Material Safety Data Sheets (MSDS) for Herbst and Dorsal materials.