"The Makura mouthguard's protective technology has been engineered for the highest levels of protection and comfort. All Makura mouthguards come complete with a durable case to keep your mouthguard clean and safe. All Makura mouthguards are fully CE compliant so that you can be confident you are buying the highest levels of safety. Sizes available: Junior (Age 11 & Under), Adult (Age 12 & Over) ? The mouthguard has passed DD 253:2001 Performance Level 1 impact tests. ? The mouthguard is made from FDA grades of EVA and TPR materials. ? The mouthguard does not contain Latex. The materials used are not currently known to cause allergic reactions or sensitization. ? Please consult your dental surgeon or orthodontist before use if you intend to use this mouthguard as a night guard. ? Unless approved by the person fitting the brace, this mouthguard should not be used when wearing braces."