Double Tube Herbst Appliance

The Double Tube Herbst Appliance is an intraoral dental device worn during sleep to advance the lower jaw (mandible) forward, reducing nighttime snoring and mild to moderate obstructive sleep apnea in adults. The customized appliance is inserted and removed nightly by the patient and adjusted by a dentist as needed.

The device consists of upper and lower acrylic base appliances connected on each side by a telescopic apparatus made of stainless steel components. Key differences from the predicate include a new methodology for attaching the telescopic components to the base appliance using wire loops and connectors, and a new adjustment method allowing 1/2 mm incremental length changes along a 15 mm range without tools. Materials are identical to predicates: sheet acrylic, cold cure acrylic resin, and stainless steel.

Not stated in this summary.

The subject device is substantially equivalent because it has identical indications for use, intended use, mode of action, and basic technological characteristics as the predicate (ATG/SM-OSA Appliance, K130130). The design differences in attachment and adjustment methodology are improvements intended to enhance safety and effectiveness rather than alter fundamental function. Bench testing confirmed the components withstand comparable forces to the predicate, and comparative risk analysis shows the same or lower risks for TMJ damage, tooth damage, and aspiration. The unrestricted lateral mandibular movement and full-arch force distribution mitigate risks identically to the predicate.