Innovation. Safety. Performance.
Technology, innovation, and safety—these are more than simply words. They’re the codes by which we work, and the pledges we make to all the athletes who put their trust in Makura mouthguards.
All of Makura’s mouthguards are CE approved and certified, having been tested by an independent third party (SATRA Technology Centre Ltd, Wyndham Way, Telford Way Industrial Estate, Kettering, Northamptonshire NN 16 8SD, United Kingdom (Notified Body Number 0321).
CE approval is required for any personal protective equipment (PPE) like mouthguards sold within the European Economic Area (EEA). In order to acquire CE certification, mouthguards must be both impact and innocuous tested to ensure the materials are not harmful and will keep users protected while playing contact sports.
Impact and Innocuous Testing
Through independent testing, our mouthguards have achieved Level 2 and 3 Impact Resistance (Level 3 offering the highest level of protection for mouth-adapted mouthguards, while Level 2 is the highest for ready-made mouthguards):
- TOKA PRO®: Level 2 Impact Resistance
- IGNIS PRO®: Level 2 Impact Resistance
- IGNIS® CONVERTIBLE: Level 2 Impact Resistance
- TEPHRA MAX®: Level 3 Impact Resistance (the highest level achievable for mouth-adapted mouthguards)
- LITHOS PRO®: Level 2 Impact Resistance (the highest level achievable for ready-made mouthguards)
As part of the CE examination and approval process for PPE, products need to undergo chemical testing to confirm the materials used are innocuous and won’t harm users.
The specific standards that apply to mouthguards are:
- BS EN 1186: 2002: This testing is required for any materials (plastics in particular) that come into contact with foodstuffs. To be tested, objects are immersed in an aqueous food simulant for four hours at 37˚C to determine global migration. Those results are measured against distilled water under the same conditions (same length of time and temperature). In order to pass, global migration must be less than 10mg/dm2 (milligrams per decimeter squared).
- BS EN 71-3: 2013: This testing is necessary for polymeric, laminates, and reinforced materials and textiles. It measures the amount of certain elements (aluminium, copper, lead, mercury, nickel, zinc, etc.) scraped off solid materials due to biting, licking, or sucking.
- PAH testing: This determines whether certain polycyclic aromatic hydrocarbons (PAHs) are present in a given material. Products can’t be sold or supplied if any rubber or plastic components that come into direct as well as prolonged or short-term repetitive contact with skin or oral cavities contain more than 1mg/kg of any of the listed PAHs.