Technology. Safety. Performance.

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.

Technology

The features that go into every Makura mouthguard are there to give you the best of both worlds, pairing uncompromised protection with unbeatable comfort.

Some of our innovations (the BOIL & BITE® fit, GELFORM® liner, SHOKBLOKER® outer, and FLEXICORE® centre) have been registered exclusively by and for us. If you see these words, you know you’re getting a Makura-quality mouthguard.

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®.

Safety

A high quality, well fitted mouthguard plays a crucial role in keeping your face, mouth, and teeth safe when playing sports.

Many people assume it’s the high-contact sports (including MMA, wrestling, rugby, football, field hockey, ice hockey, and lacrosse) that produce the greatest number of injuries. As a result, these are typically the only sports for which athletic associations require their participants to wear a mouthguard. In reality, it’s the ones you wouldn’t expect (like soccer, baseball, and basketball) that can be the most hazardous. Players often assume that they won’t need a mouthguard, which leaves them vulnerable. Studies of non-mouthguard-mandated sports have found that orofacial and dental injuries account for anywhere from 3% to 38% of total injuries, while players who choose not to wear a mouthguard are 1.6 to 1.9 times as likely to suffer some type of orofacial trauma.

Remember: whatever your sport—no matter your level or how often you play—a mouthguard is always the right move when it comes to protecting yourself from contact-related injuries.

How Do Mouthguards Keep You Safe?

Getting hit in the face is a hazard that comes with playing any sport. But don’t worry, that’s what your mouthguard is there for!

Mouthguards work by slowing and distributing the force from a direct impact, whether by a person, hard surface, or an object like a ball, puck, or stick. A hit like this will cause shock waves to reverberate throughout your mouth, face, and skull. Mouthguards are engineered to capture the energy from the blow, disperse it as they contract, and spread it again as they expand back into shape.

To put it simply, a mouthguard acts as a shock absorber for your mouth and teeth.

What Types of Injuries Does a Mouthguard Protect Against?

The two main types of injuries that mouthguards help prevent are dental and orofacial traumas:

  • Dental Injuries: The most frequent type of dental trauma for athletes is a chipped tooth, though more serious ones like dislodged or impacted teeth are not uncommon either. However severe it might appear, these types of wounds always need to be checked by a dentist or other oral healthcare provider. There could be problems with the affected or surrounding teeth that might not be visible to the untrained eye.
  • Orofacial Injuries: These include soft tissue injuries like contusions (bruising that doesn’t penetrate the skin), abrasions (injuries where the skin was grazed (friction), but not ruptured), and lacerations (where the skin is breached and often leads to bleeding).

Keep in mind that, although mouthguards excel at minimizing the harm associated with dental and orofacial traumas, they do not prevent concussions or other types of mild traumatic brain injuries (MTBIs). There have been some studies that have attempted to prove a link in the past, but the evidence has never been strong enough to demonstrate a conclusive link.

The Right Fit Matters

How your mouthguard fits has an impact on how well it keeps you safe and how comfortable you are while wearing it.

  • Breathing and Speech: Your mouthguard shouldn’t hinder your ability to breath or speak in any way. If it does, it’s not the right fit.
  • Security: You shouldn’t have to clench your teeth to keep your mouthguard in place, nor should you be able to loosen it easily with your tongue. You’ll only end up adjusting it constantly if it doesn’t sit tightly against your upper teeth.
  • Comfort: If your mouthguard makes you gag, that’s a problem. Ideally, you want it to end somewhere between your first and second molars while avoiding too much of your soft palate.

Especially with mouth-adapted mouthguards, it’s important to follow the manufacturer’s guidelines to ensure you get a proper fit every time. Wearers also need to take proper care of their mouthguards (cleansing them with mild antimicrobial agents before and after use and not exposing them to direct sunlight or other sources of heat) and inspect them regularly to make sure they aren’t damaged.

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.

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 analysis 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 decimetre squared). To put it another way, this test affirms that chemicals won’t transfer from the plastic into users’ bodies in toxic quantities.
  • 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.

Though not necessary for CE approval, we can also confirm that Makura mouthguards contain neither Formamide nor BPA.

Why Is CE Certification Important?

Whether you’re a distributor or a mouthguard user, CE certification matters.

For distributors wanting to sell PPE like mouthguards within the EEA, it’s the law that they must be CE certified. Ultimately, what CE approval does is provide harmonization. Instead of having to jump through a variety of independent national regulatory hurdles, you gain automatic access to all of the countries and markets that are part of the EEA by completing the procedure once.

Even better: choosing Makura as your mouthguard supplier means you don’t have to involve yourself with the CE certification process. We’ve already taken all the necessary steps to ensure all of our mouthguards are fully CE certified and compliant, which means they’re ready for you to take right to your customers.

If you’re an athlete using a mouthguard, the CE mark reassures you that the product you’re putting in your mouth and relying on to keep you safe has been rigorously tested to ensure it meets international standards, doesn’t contain materials that will harm you, and will keep you protected from contact-related injuries.

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