Airway Administration, a developer of superior oral home equipment, has achieved FDA clearance for its Nylon flexTAP, one of many first digitally printed single-point midline oral equipment units for sleep apnea. The gadget redefines affected person care by combining patented Vertex Know-how with unparalleled consolation and efficacy, now FDA-cleared for gentle to average obstructive sleep apnea (OSA).
Key options and advantages embody: digitally printed medical-grade Nylon; patented Vertex Know-how; 17mm vary of development; ultra-thin customized TAP trays; BPA-free and metal-free; no chunk registration required; Mouth Protect and AM Aligner included; and a 4-year guarantee.
“We’re thrilled to introduce the Nylon flexTAP, a game-changer in oral equipment remedy,” mentioned Charles Collins, CEO of Airway Administration. “Suggestions from key opinion leaders in our TAP Sleep Care system highlights its superior effectiveness and affected person consolation. Peer-reviewed research additionally affirm that our patented mouth protect, which promotes nasal respiration, considerably improves remedy outcomes. This innovation underscores our dedication to advancing sleep well being.”
Since 2015, the American Academy of Sleep Drugs (AASM) and American Academy of Dental Sleep Drugs (AADSM) have really useful oral equipment remedy for gentle to average sleep apnea. The Nylon flexTAP units a brand new benchmark by leveraging digital printing expertise, eliminating the necessity for chunk registration whereas sustaining precision.
Manufactured within the USA, the gadget is now out there via Airway Labs, with PDAC protection (E0486) pending.
