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Dentemp Pro-Comfort is indicated for protection against nighttime teeth grinding (bruxism). It is intended to reduce damage to teeth and prevent the noise associated with teeth grinding and bruxism.

Dentemp Pro-Comfort Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is manufactured with a two-shot, injection molded process. The first shot is a hard base of Ethylene Methyl Acrylate material (EMA), which contacts the lower tooth surfaces during grinding and prevents grind-through. The second shot is a soft, moldable surface layer of Ethylene Vinyl Acetate material (EVA), which is formed to hug the upper teeth for a comfortable fit. It is a custom fit dental guard, formed to an individual user's mouth by the traditional heat and form fitting technique. It is a full-occlusal guard worn on the upper teeth, providing a barrier to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth caused by bruxism and preventing the noise associated with teeth grinding.

The Anti Grinding Guard is a mouth guard intended to protect against grinding and clenching.

The Anti Grinding Guard is an over-the-counter (OTC), flexible and moldable one-piece dental mouth guard, which is used as a barrier between teeth for individual s who grind their teeth. The anti Grinding Guard is intended to be worn while sleeping. The guard is constructed of 100% thermoplastic ethylene-vinyl acetate copolymer. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. The mouth guard Is one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.

The Goyo Mouthpiece S is indicated for use as a protection against bruxism or nighttime teeth grinding. The device is designed to reduce tooth damage and reduce the noise associated with bruxism or teeth grinding.

The mouthguard is an over-the-counter, flexible and moldable, one-piece dental mouthguard used as a barrier between the teeth for individuals who wish to prevent teeth grinding during sleep. The Goyo Mouthpiece S is made of ethylene vinyl acetate (EVA). The mouthguard material is conformable to wear and it can be self-fitting by heating the mouthguard in boiling water until it becomes malleable to fit on the upper teeth of the oral cavity. The Goyo Mouthpiece S comes in one model/size, is reusable by a single individual eighteen (18) years of age or older, and is supplied non-sterile. The wearing period of the mouse guard is generally not more than twelve (12) hours a day and it is recommended to replace it with the new mouthguard in the one (1) month.

The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

The Mouth Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's teeth after the guard has been heated via submersion in boiled water. The fully occlusive guard is worn on the upper teeth, maintaining separation between the upper and lower teeth, thereby reducing the noise and damage associated with teeth grinding.

The FBCC Night Guard is indicated for protection of teeth and restorations against grinding and clenching.

The FBCC Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).

Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.

Protect-It Custom Fit Dental Guard is an over-the-counter device to be used by lay people for protection against the effects of nighttime teeth grinding. It is made of a single thermoplastic resin, ethylene vinyl acetate copolymer, EVA, which is easily molded to the teeth when heated. It is a full-occlusal guard worn on the upper teeth, providing a cushion to separate the upper and lower teeth and keep them apart while sleeping, thus reducing the damage to teeth associated with bruxism.

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.

1. As an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing; 2. Protection against bruxism or nighttime teeth grinding and reduce damage and the noise associated with bruxing and/or grinding.

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The DenTek™ Fresh Protect™ Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.

The DenTek™ Fresh Protect™ Dental Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of an ethylene/vinyl acetate copolymer and utilizes a ready-to-wear, one-size-fits-all design. The fully occlusive guard is worn on the lower teeth, maintaining separation between the upper and lower teeth, thereby preventing the noise and damage associated with teeth grinding.

· 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.