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The JS Dental Lab Mouth Guard is intended for protection against bruxism and teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.

The JS Dental Lab Mouth Guard (herein referred to as Subject Device) is a patient contact protective custom-fit mouth guard that covers the upper teeth and lower teeth to prevent premature tooth wear and noise caused due to bruxism and teeth grinding. It fits over upper teeth or lower teeth during sleep. The Subject Device can offset the effects of bruxing or teeth grinding while protecting teeth from daily wear and tear. The Subject Device is created based on the user's teeth impression and manufactured using the biocompatible material, equivalent to the Thermoformed Mouthguards/Nightguards (herein referred to as Predicate Device, K121365). The Subject Device contains biocompatible materials, namely, Erkodur or Splint Biocryl, Erkoloc-Pro, Erkoflex-95, EVA Based Clear Mouthguard Material and BIOPLAST and is available in four different variations. All the biocompatible materials used are ISO-certified, BPA-free, and are cleared for dental use in humans.