Sleep Apnea Product Guide

Overview: Dandy offers the Herbst and Dorsal appliances as effective, digital-workflow-based alternatives to CPAP for managing mild-to-moderate obstructive sleep apnea (OSA).

Prerequisites

  • A clinical diagnosis of mild-to-moderate obstructive sleep apnea or a history of snoring.

  • A digital scan or impression for custom fabrication.

Compare Sleep Apnea Appliances

Dandy uses digital workflows and industry-leading materials to produce two highly accurate anti-snoring devices: the Herbst Appliance and the Dorsal Appliance. These devices advance the mandible to prevent airflow obstruction during sleep.

Understand the Herbst Appliance

The Herbst Appliance is a one-piece construction. It features two adjustment mechanisms located on the buccal (outer) area of the upper and lower portions.

Benefits of the Herbst Appliance

  • Allows for lateral and vertical movement during sleep.

  • Offers an adjustable design to incrementally advance the mandible.

  • Uses minimal acrylic to preserve tongue space for patient comfort.

  • Qualifies for Medicare coverage.

Herbst Regulatory and Medicare Specifications

  • FDA Status: 510(k) clearance and Class II FDA approval.

  • HCPCS Code for PDAC: E0486.

  • Premarket Submission Number: K103076.

  • Regulation Number: 872.5570.

Understand the Dorsal Appliance

The Dorsal Appliance is a two-piece design. It uses separate upper and lower acrylic portions that engage via built-in acrylic fins to position the mandible.

Benefits of the Dorsal Appliance

  • Provides the greatest range of motion and lateral excursion.

  • Uses a two-part design without metal hinges to improve patient comfort.

  • Includes advancement screws on the upper portion for precise mandibular positioning.

Dorsal Regulatory Specifications

  • FDA Status: 510(k) clearance and Class II FDA approval.

  • Premarket Submission Number: K103076.

  • Product Code: LRK.

  • Note: The Dorsal Appliance does not have PDAC approval.

Review Medical and Dental Billing Codes

Insurance providers require specific codes for sleep appliance fabrication and adjustments.

Medical Billing Codes

  • E0486: Oral device or appliance used to reduce upper airway collapsibility.

  • Note: The replacement clause for this code varies by insurance provider.

Dental Billing Codes

  • D9947: Custom sleep appliance fabrication and placement.

  • D9948: Adjustment of custom sleep apnea appliance.

  • D9949: Repair of custom sleep appliance.

Review Home Sleep Study Codes

These codes apply to unattended sleep studies using various portable monitors.

CPT Home Sleep Study Codes

  • 95800: Unattended sleep study with heart rate, oxygen saturation, and respiratory analysis.

  • 95801: Unattended sleep study with respiratory analysis.

  • 95806: Unattended sleep study with heart rate, oxygen saturation, respiratory airflow, and effort.

G Home Sleep Study Codes

  • G0398: Type II portable monitor (minimum 7 channels).

  • G0399: Type III portable monitor (minimum 4 channels).

  • G0400: Type IV portable monitor (minimum 3 channels).

Related Information

 

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