Dental Manufacturer Great Lakes Launches World's First FDA-Cleared 3D-Printed Nylon Oral Appliance

DentalGoodNews｜April 27, 2026, Great Lakes Dental Technologies (hereinafter referred to as "Great Lakes"), a comprehensive dental manufacturing company, announced an exclusive laboratory partnership with medical device company TAP Sleep Care, officially launching the world's first FDA 510(k)-cleared nylon oral aligner, Nylon flexTAP®, manufactured using single-point midline digital printing. This product is primarily used to treat snoring and mild-to-moderate obstructive sleep apnea (OSA).

According to official introduction, the core feature of Nylon flexTAP® lies in its digital manufacturing process. The aligner is made of medical-grade white nylon material, realized through 3D Printing technology, offering ultra-light, ultra-thin, and precisely fitting characteristics. Great Lakes states that the product is completely metal-free and integrates the patented Vertex Technology®, allowing patients to achieve synchronized vertical and horizontal displacement adjustments of the upper and lower jaws at home through a single midline adjustment point. Additionally, each set of aligners is equipped with a Mouth Shield to promote nasal breathing and alleviate dry mouth, thereby enhancing overall treatment efficacy.

According to public information, Great Lakes was founded in 1965 and is headquartered in New York. It is one of the largest orthodontic laboratories in North America, offering over 4,000 products and services, with a focus on digital workflows and orthodontic and sleep airway solutions.

TAP Sleep Care, a platform under Airway Management, was founded by Dr. Keith Thornton in 1997. The platform is now supported by over 50 independent peer-reviewed studies. TAP Sleep Care stated that the newly launched nylon version is part of the TAP product line, aiming to offer a more comfortable option for patients seeking alternatives to traditional CPAP (Continuous Positive Airway Pressure) therapy.

According to previous reports by DENTALGOODNEWS (Leading Dental Industry Media, DGN), the 美国牙科协会｜American Dental Association｜ADA has called for enhanced collaboration between dentists and the sleep medicine community to address the severe underdiagnosis of sleep-disordered breathing. In the field of non-invasive OSA treatment, Vivos has previously obtained approval for an oral aligner that can be used for severe OSA treatment.