The first FDA-approved 3D printed oral appliance for sleep apnea is here

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September 22, 2025 Materials 176

FDA-approved 3D printed Nylon flexTAP® oral appliance for mild-moderate OSA, featuring personalized comfort and advanced airway management.

Airway Management recently announced that its developed Nylon flexTAP® (Nylon Flexible TAP Appliance) has received approval from the U.S. Food and Drug Administration (FDA). Reportedly, this is the first oral appliance for sleep apnea manufactured using 3D printing technology, now FDA-approved for treating mild to moderate obstructive sleep apnea (OSA).

Core Features and Advantages

Medical-Grade Nylon Digital Printing: Utilizes advanced digital printing technology to achieve precise personalized fitting design, prioritizing patient comfort.

Patented Vertex Technology®: Enables dual-axis (vertical and horizontal) movement, maximizing airway space and reducing the need for excessive jaw protrusion—particularly suitable for patients with larger tongues or narrow airways.

17mm Protraction Adjustment Range: Allows incremental adjustments as precise as 1/3mm to achieve optimal jaw protrusion position and improve airway patency.

Ultra-Thin Custom TAP Tray: Delivers exceptional comfort without compromising therapeutic efficacy, making it the thinnest custom TAP appliance currently available.

BPA-Free and Metal-Free Construction: Manufactured with biocompatible materials to enhance user safety.

No Bite Registration Required: Streamlines the fitting process, saving time for both clinicians and patients.

Includes Oral Protective Shield and AM Aligner®: The only oral appliance equipped with accessories to promote nasal breathing and enhance treatment efficacy. The AM Aligner is a morning exercise tool designed to alleviate common side effects associated with Oral Appliance Therapy (OAT).

4-Year Warranty: Ensures long-term reliability and provides users with greater peace of mind.

Industry Voices

"We are thrilled to introduce the Nylon flexTAP®, a true game-changer in oral appliance therapy," said Charles Collins, CEO of Airway Management. "Feedback from key opinion leaders within our TAP Sleep Care network highlights its exceptional efficacy and patient comfort, while peer-reviewed studies confirm that our patented oral shield—designed to promote nasal breathing—significantly enhances treatment outcomes. This innovation underscores our unwavering commitment to advancing sleep health."

A New Standard in Sleep Apnea Treatment

Since 2015, the American Academy of Sleep Medicine (AASM) and the American Academy of Dental Sleep Medicine (AADSM) have recommended oral appliance therapy as a treatment for mild to moderate sleep apnea. By leveraging digital printing technology, the Nylon flexTAP® sets a new benchmark as the first FDA-approved device of its kind, eliminating the need for bite registration while maintaining precision.

Manufactured in the United States, the device is currently available through Airway Labs (a subsidiary of Airway Management), with its PDAC code (E0486) approval pending under the Medicare Durable Medical Equipment classification.

About Airway Management

Airway Management is the innovative developer of the TAP Sleep Care product portfolio and a leader in advanced oral appliance technology. The efficacy of the company's products is supported by over 50 independent peer-reviewed studies—more than any other device manufacturer in its category—demonstrating proven reliability in treating sleep-disordered breathing.

The TAP product line (including myTAP, flexTAP, and customized hybrid solutions like TAP PAP) offers comfortable, minimally invasive alternatives to Continuous Positive Airway Pressure (CPAP) therapy, helping patients achieve restful sleep and improved quality of life. Committed to excellence, the company provides clinicians, healthcare professionals, and lab technicians with high-quality, customizable treatment solutions for snoring and obstructive sleep apnea, empowering patients to wake up refreshed and revitalized.