Technology

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.

BOIL & BITE ®

Delivering a custom fit for maximum comfort.

Available in the TOKA PRO®, IGNIS PRO®, IGNIS® CONVERTIBLE, and TEPHRA MAX®.

Designed for Use with Braces

Our ready-made mouthguard was created specifically for wearers of fixed braces.

Available in the LITHOS PRO®.

GELFORM® Liner

Softened gel creates precise mould of the teeth for a secure fit.

Available in the IGNIS PRO®, IGNIS® CONVERTIBLE, and TEPHRA MAX®.

AIRTHRU Channel

Improves breathing while the jaw is closed.

Available in the TOKA PRO®, IGNIS PRO®, IGNIS® CONVERTIBLE, TEPHRA MAX®, and LITHOS PRO®.

SHOKBLOKER® Outer

Absorbs and diffuses frontal and transverse impact.

Available in the TOKA PRO®, IGNIS PRO®, IGNIS® CONVERTIBLE, TEPHRA MAX®, and LITHOS PRO®.

SLIPSAFE Pads

Raised areas on the underside prevent slipping while the jaw is closed.

Available in the TOKA PRO®, IGNIS PRO®, IGNIS® CONVERTIBLE, TEPHRA MAX®, and LITHOS PRO®.

FLEXICORE®

Provides reinforced strength and additional protection.

Available in the TEPHRA MAX®.

ORTHO CHANNEL

Fits over fixed braces for a secure and comfortable fit.

Available in the LITHOS PRO®.

Certifications

CE Certification

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.

Safety

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):

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.

Contact us to learn more about Makura’s mouthguards and their certifications!