Nylon flexTAP(R)

The Nylon flexTAP is a custom-fit oral appliance designed to reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years and older. It consists of upper and lower trays that fit on the teeth, connected by an adjustment mechanism that allows the lower tray to be advanced relative to the upper tray.

The subject device uses digitally printed medical-grade nylon material for the upper and lower trays, compared to the predicate device's material. The adjustment mechanism employs a dial system (identical to reference devices) rather than the predicate's hex key system. Both mechanisms achieve identical single-point midline advancement functionality and allow titration with the appliance in the mouth.

Not stated in this summary. The document references functional testing for durability after multiple cleanings, flexural strength testing, force testing, drop testing, and biocompatibility testing for surface-contacting mucosal membrane contact with duration >24 hours <30 days, but does not cite specific ISO, IEC, or ASTM standards.

The device is substantially equivalent because the two identified differences—material composition and titration mechanism design—do not raise new safety or efficacy questions. The nylon material is supported by biocompatibility certification and is identical to previously-cleared reference devices (K181482 and K143244). The dial adjustment mechanism is functionally identical to the reference device's dial and achieves the same single-point advancement principle as the predicate's hex key. All other device characteristics, indications, contraindications, testing requirements, and principles of operation remain identical to the predicate.