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The SleepRight® Select-Comfort™ Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. The SleepRight® Select-Comfort™ Dental Guard is indicated for the protection against teeth grinding, bruxism, and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

The subject device is the second-generation to the SleepRight® Select-Comfort™ Dental Guard, also referred to as the SleepRight® Original (K100545) back in 2010. The SleepRight® Select-Comfort™ Dental Guard is a self-adjustable partial coverage protector that acts as a barrier between the upper and lower posterior teeth to protect the teeth against bruxism or nighttime teeth grinding. The guard contains two adjustable bite pads that are connected by a thermal band (also referred to as the strap). The bite pads contain an internal core that is fully encapsulated by a thermoplastic material; and can be adjusted in five settings: extra-small, small, medium, large, and extra-large. No boiling or microwaving is required to fit the guard to the teeth, it is ready for use right out of the package. The bite pads may be adjusted to five settings that accommodate different dental arch sizes, where the front edge of the bite pad should rest between the upper third tooth (cuspid) and the fourth tooth (premolar). For a larger fit, the bite pads can be adjusted backward; and for a smaller fit, the bite pads can be adjusted forward. The thermal band should rest between the lower lip, cheek, and gums.

Protection against bruxism or nighttime teeth grinding Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding Protection against teeth grinding, bruxism, and jaw clenching Short-term pain relief from muscle spasm due to occlusal interference Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle

The subject devices, the SleepRight® ProRx® + Custom Dental Guard (K212706) and the SleepRight® ProRx® Custom Dental Guard (K212706) are the second-generation quard to the SleepRight® ProRx™ Custom Dental Guard (K172223). Both subject devices (K212706) are completely identical to each other, except for the material that makes up the internal core of each guard. The subject devices (K212706) are both a full occlusal custom formable protector that acts as a barrier between the upper and lower teeth to protect the teeth against bruxism or nighttime teeth grinding. The subject devices (K212706) both contain the exact same horizontal core design with a vertical sectional lattice structure, primarily wrapping around the labial and buccal side of the teeth, as well as around the lingual posterior side of the teeth. The core and lattice are fully encapsulated by a moldable thermoplastic material in both guards. The guards are designed to be fit using the exact same method to heat the guard in hot (not boiling) water until it becomes malleable and can be formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls/lattice are gently pushed to surround the teeth. The lattice retains the malleable material up against the teeth until the device hardens in approximately four minutes.

· Protection against bruxism or nighttime teeth grinding · Reduce damage to the teeth and to prevent the noise associated with bruxing or grinding · Protection against teeth grinding, bruxism, and jaw clenching · Short-term pain relief from muscle spasm due to occlusal interference · Prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle

The SleepRight® ProRx® Custom Dental Guard (K193577) is the second-generation guard to the predicate SleepRight® ProRx™ Custom Dental Guard (K172223). The SleepRight® ProRx® Custom Dental Guard (K193577) is a full occlusal custom formable protector that acts as a barrier between the upper and lower teeth to protect the teeth against bruxism or nighttime teeth grinding. The guard contains a horizontal core with a vertical sectional lattice structure, primarily wrapping around the labial and buccal side of the teeth, as well as around the lingual posterior side of the teeth. The core and lattice are fully encapsulated by a moldable thermoplastic material. The guard is heated in hot (not boiling) water until it becomes malleable and can be formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls/lattice are gently pushed to surround the teeth. The lattice retains the malleable material up against the teeth until the device hardens in approximately four minutes.

The SleepRight® ProRx® Custom Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. Protection against teeth grinding, bruxism and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.

The SleepRight® ProRx® Custom Dental Guard is a full occlusal custom formable protector that provides a barrier between the upper and lower teeth. Contains a hard core material enveloped by a moldable thermoplastic. The guard is heated in hot (not boiling) water until it becomes malleable and then formed to the consumers upper teeth. To achieve a custom fit, the guard is inserted into the mouth and the side walls are gently pushed up to surround the teeth. The material hardens in roughly one minute. The SleepRight® ProRx® Custom Dental Guard has a tensile strength of 29 Mpa and a Shore D hardness value comparable to the primary predicate device, the ProTech Dent®.