How many classes of medical devices are sports mouth guards

Class Zero medical device. Sports mouthguard is not a medical device management. According to the query of the State Drug Administration on May 17, 2022 released "2020-2021 Medical Device Classification Definition Results Summary" shows that the fifth recommended not to be managed as a medical device 197 products. Among them, the fourteenth item of customized motion protectors: thin-shelled. A personalized product based on the patient's intra-oral data through a heat laminated film process. Made of thermoplastic polyurethane, polyethylene terephthalate-1,4-cyclohexanedimethanol ester. Provided as a reusable non-sterile product. Used for tooth protection during sports. Worn on the upper and lower teeth during use to prevent direct contact between the upper and lower teeth, utilizing the high elasticity of the guard to reduce the damage to the teeth caused by transient forces during sports impact.