CE CERTIFICATION COMPLIANCE in EU Regulation 2016/425

This mouthguard lobloo SLICK and PRO-FIT carries the CE Marking to denote its compliance with the requirements of the Regulation (EU) 2016/425 as a 2nd Category PPE = Personal Protective Equipment against medium risks. 

Annex II is compliant with EN ISO 13688:2013 and other requirements as per the Internal Protocol of the Notified Body is identical to the PPE object of the CE certificate n ° 716195201/OE

The performances of the mouthguard have been verified by RICOTEST, Notified Body nr. 0498 (Via Tione 9, 37010 Pastrengo - Verona - Italy) on the basis of laboratory tests performed in accordance with an Internal Protocol. The mouthguard has passed the impact force transmission test performed with a flat impactor (2.5 Kg) striking the protector on the incisal surface, frontal buccal flange and palatal flange area at 5J. 

The Manufacturer

FRONTLIFE AB

Krukmakargatan 28, Stockholm – SWEDEN

The EU Declaration of Conformity is provided together with this Information Notice.

The "CE" means that the product satisfies the basic health and safety requirements of Regulation (EU) 2016/425 – Annex II

MATERIALS AND MANUFACTURING

All materials used, as well as the applied processing techniques, have been chosen to meet the requirements of Regulation (EU) 2016/425. The materials used are not currently known to cause allergic reactions or sensitization.

USE for which the mouthguard is intended

lobloo Slick and PRO-FIT is the result of extensive laboratory testing and field trials to perfect both of these aspects. A hard-outer layer acts like a shield, efficiently spreading impact forces without feeling plasticky in your mouth. The inner layer, meanwhile, is made from loboo’s proprietary mould material, which not only ensures a perfect fit; it also retains its shape and superior energy-absorption in the long term. lobloo Slick are meant to reduce the risk of injuries to the mouth when practicing contact sports, like for instance martial arts, rugby or similar sports.

What you need:

• Heat source
• Cold water
• Spoon
• Timer

Practice our vacuum technique:

1. With an empty mouth, push your tongue against the front of your palate.
2. Then suck as hard as you can with your mouth closed.
3. Suck repeatedly, and you will feel how a vacuum is gradually created inside your mouth.
4. Once you know the vacuum technique, it’s time to create the perfect mould.

Moulding and fitting

1. Bring a pot of water to boil and remove it from the burner or hotplate.
2. Drop in your mouthguard and let it sit (see below);
   SLICK Large +14yrs and let it sit for 45 seconds.
   SLICK Medium 10-13yrs and let it sit for 35 seconds.
   PRO-FIT Large +14yrs and let it sit for 40 seconds.
   PRO-FIT Medium 10-13yrs and let it sit for 30 seconds.
3. Shake off the hot water.
4. Pinch the rims of the mouthguard together and push the ends toward the middle. This will ensure a tight fit during the moulding process.
5. Put the mouthguard directly into your mouth, checking the mirror to ensure that your front teeth or on either side of the centre. Then bit straight down as far as you can.
6. To create a single, accurate imprint of your teeth, it’s important that you do not grind your teeth.
7. Now use the vacuum technique while pressing the outside of the mouthguard with your fingers.
8. Keep doing this until you feel that the mouthguard has virtually fused with your gums and teeth (and don’t worry if moulding material is pushed out through the slits in the mouthguard, it is a key part of the design).
9. Remove and leave in cold water for 30 seconds.
10. The perfect fit that you just achieved is key to lobloo’s superior impact protection.

SAFETY WARNINGS and LIMITATIONS

·    NO MOUTHGUARD CAN PROTECT AGAINST ALL INJURIES!

·    Do not chew the mouthguard. If it is chewed and/or not used as intended, its effectiveness in terms of fit, protection and durability will be greatly reduced.

·    Do not use the mouthguard with braces unless this has been approved by a dentist or orthodontist.

·    For users whose mouth is still in growth, the fit of the mouthguard must be checked regularly.

·    Replace the mouthguard immediately if it shows signs of wear, cracks or splits or if there is any doubt about its condition.

CARE, MAINTENANCE, STORAGE

·     Clean the mouthguard with fresh water after each use. Do not use mouthwashes, toothpaste or other detergents.

·     When not in use, the mouthguard must be stored in the bag it is provided with in a dry place, at room temperature. Do not use dryer or heating devices.

·     Avoid storing mouthguards under heavy weights in order for them to keep their shape.

·     Do not expose the mouthguard to direct sunlight nor to extreme heat for lengthy periods of time.

Duration and Disposal instructions

The obsolescence of the mouthguard depends upon the regularity and severity of its use. These protectors should normally remain serviceable for one and a half years. However, it is strongly advised to visually check them after each use. 

At the end of the mouthguard’s useful life be sure to not discard it in the natural environment: please follow local / national environmental regulations. Further information regarding these regulations can be obtained from local authorities.

Signed for and on behalf of FRONTLIFE AB

Stockholm, 2019/12/23

Usama Aziz, Chief Officer