Dentemp Pro-Comfort Dental Guard

The Dentemp Pro-Comfort Dental Guard is an over-the-counter mouthguard designed to protect against nighttime teeth grinding (bruxism). It is a custom-fit device worn on the upper teeth that acts as a barrier between upper and lower teeth to reduce tooth damage and prevent grinding noise. Users heat and mold the guard to fit their individual teeth.

The device is manufactured via two-shot injection molding with a hard Ethylene Methyl Acrylate (EMA) base and a soft, moldable Ethylene Vinyl Acetate (EVA) surface layer. The hard base features T-Bars (finger-like protrusions) that hold the soft material in place during forming. It is a full-occlusion guard measuring 40mm L × 64mm W × 9mm H and weighing 7 grams, designed to be cleaned with toothpaste and cool water.

The FDA guidance document ISO 10993-1 (Biological evaluation of medical devices) was used to assess biocompatibility and analytical testing requirements. No specific ASTM, IEC, or other consensus standards are cited.

The subject device is substantially equivalent because it has identical materials (EMA hard base and EVA soft layer), identical indications for use (protection against bruxism), and identical intended use (barrier to separate teeth) as the predicate device (DenTek Custom Comfort Nightguard Version 2, K091660). The minor design differences—T-Bars for fit versus a concave curve, and slightly larger dimensions—do not raise new safety or effectiveness concerns. A comparative study confirmed the T-Bar technology performs equivalently to the reference device's design, and an in-home use test validated equivalent forming, fit, comfort, and functionality.