Overview: Dandy offers the Preferred Nylon Sleep MAD and the Freedom Nylon Sleep 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.
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 MADs: Freedom Nylon Sleep and the Preferred Nylon Sleep Appliances. These devices advance the mandible to prevent airflow obstruction during sleep.
Understand Preferred Nylon Sleep Appliances
The Preferred Nylon Sleep Appliance is a one-piece construction. It features an adjustment mechanism located on the buccal (outer) area of the upper and lower portions.
Benefits of the Preferred Nylon Sleep Appliance
Allows for lateral and vertical movement during sleep.
Offers an adjustable design to incrementally advance the mandible.
Uses minimal nylon to preserve tongue space for patient comfort.
Qualifies for Medicare coverage.
Additional Benefits
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Traction-style advancement system
- Designed to encourage mouth closure during sleep
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Supporting:
- Nasal breathing
- Minimizing mandibular drop
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Lightweight two-piece nylon construction
- Offers exceptional comfort with a completely metal-free design
- Minimal bulk
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Beneficial for patients with:
- Mouth breathing tendencies
- TMJ sensitivity
- Those seeking a durable nylon alternative with a greater titration range and adjustability
Understand the Freedom Nylon Sleep Appliances
The Freedom Nylon Sleep Appliance is a two-piece design. It uses separate upper and lower nylon portions that engage via built-in nylon fins to position the mandible.
Benefits of the Freedom Nylon Sleep Appliance
Provides the greatest range of motion and lateral excursion.
Uses a two-part design without metal hinges to improve patient comfort.
Includes advancement clips on the upper portion for precise mandibular positioning.
Additional Benefits
- Push-style mechanism.
- Allows for greater mandibular opening freedom during sleep.
- Effective advancement and precise titration capabilities.
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Lightweight, metal-free nylon design.
- Improves patient comfort.
- Allows easier speaking and drinking compared to traditional appliances.
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Ideal for patients who desire:
- Greater jaw mobility
- Posterior comfort
- Simplified adjustment capabilities
- A highly durable appliance design
Freedom Nylon Sleep Appliance Regulatory and Medicare Specifications
- FDA Status: 510(k) clearance and Class II FDA approval.
HCPCS Code for PDAC: K1027.
Premarket Submission Number: K171576.
Regulation Number: 872.5570.
Preferred Nylon Sleep Appliance Regulatory and Medicare Specifications
- FDA Status: 510(k) clearance and Class II FDA approval.
HCPCS Code for PDAC: E0486.
Premarket Submission Number: K143244.
Regulation Number: 872.5570.
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.
K1027: Custom-fabricated oral appliances worn at night to treat obstructive sleep apnea (OSA) without the use of a fixed mechanical hinge.
Note: The replacement clause for these codes varies by insurance provider.
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Instructions for Use