Park Dental Nylon MAD

The Park Dental Nylon MAD is a custom-made, removable oral appliance consisting of two intraoral trays connected by an adjustable interlocking rigid rod. It is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults by advancing the lower jaw during sleep to increase pharyngeal airway space.

The device uses CAD/CAM design with selective laser sintering manufacturing to produce customized splints made of polyamide type 12 polymer. It features adjustable mandibular advancement up to 5 mm in 1 mm increments and vertical opening up to 8 mm. The connector length ranges from 16–26 mm, with mandibular splint button protrusions interfacing with adjustable rods.

ISO 10993-1 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' was used for biocompatibility assessment. Durability testing, fatigue testing, and internal manufacturing validation for dimensional accuracy were also performed.

The Park Dental MAD is substantially equivalent to the predicate Panthera Anti-Snoring X3 Device because they share identical indications for use, the same mechanism of action (mandibular advancement), identical product codes and classification, the same materials and manufacturing processes (3D printing of polyamide), and comparable technological features. No clinical studies were deemed necessary due to these material and technological similarities.