Therapy · Material and manufacture
Medical silicone.Well-thought-out shape.
The FaceFormer sits in your mouth every day, in contact with the mucous membranes, teeth and gums. That is why material and shape are no minor matter.
The material
Tested for mucosal contact
Medical silicone
The FaceFormer is made from the liquid silicone LSR 4030 by Momentive Performance Materials, a material for medical applications. It is both dimensionally stable and elastic.
Tested for biocompatibility
The material was tested for biocompatibility in accordance with ISO 10993 (Parts 6, 10 and 11) and USP Class VI, with tests on systemic tolerance, skin reaction and implantation. All tests were passed.
Free from harmful substances
Free from bisphenol A (BPA), phthalates, plasticisers and latex.
Tempered
After manufacture, every FaceFormer is tempered for several hours. This stabilises its elasticity, relieves internal stresses and drives out volatile components.
The shape
Membrane and lip wedge
The membrane is highly elastic and fits snugly into the oral vestibule, between the lips, cheeks and gums. Upwards and downwards it extends into the mucobuccal folds, and sideways as far as the back molars. This allows it to adapt to different jaw shapes and tooth positions and to distribute pressure evenly over a wide area.
The lip wedge is oval and bevelled all the way round. It is connected to the membrane without any opening into the oral cavity, which is why a stable negative pressure can form when you swallow. The bevel acts like a guide track along which the lips align themselves towards the membrane during training.
Hands-on
The FaceFormer in 3D
The membrane sits in the oral vestibule, and the lip wedge protrudes between the lips. The two are connected without any opening to the oral cavity. Drag to rotate; the dots show the parts. Below the model, you can switch between ZERO, ONE blue and ONE clear. The shape is the same, only the material differs.
Drag to rotateMembrane Highly elastic. It lies in the oral vestibule between the lips, cheeks and gums and extends sideways as far as the back molars.
Lip wedge Oval and bevelled all round. It protrudes between the lips and is joined to the membrane without an opening to the oral cavity.
Material Medical-grade liquid silicone (LSR 4030), tested for biocompatibility according to ISO 10993 and USP Class VI, free from BPA, phthalates, plasticisers and latex.
Two levels of firmness
Same shape, different material
All FaceFormers come in the same one-size-fits-all format. They differ only in the firmness of the material.
FaceFormer ZERO
Softer and even more elastic. For getting started, for children up to ten years of age and for night-time use.
FaceFormer ONE
Firmer, in blue or clear. For advanced daytime training, after a few weeks with the ZERO.
Hygiene and care
How to keep your FaceFormer clean
Rinse
Rinse under warm water after every training session.
Store
Store it in the hygiene box. It is made of polypropylene and protects the FaceFormer between sessions.
Boil
At home, the FaceFormer can be sterilised in boiling water for about 20 seconds. In clinics it is autoclaved.
Just for you
Everyone uses their own FaceFormer. If it is damaged, for example by biting on it, replace it.
Drag to rotateDurability
When a replacement makes sense
Keeps its shape for several months
With regular use three times a day, in our experience a FaceFormer keeps its shape for about six months. Exactly how long depends on how much it is used.
Material fatigue from training
The many daily pulling and pressure loads put strain on the silicone over time. As with any elastic material, its resilience decreases over time. This is a normal ageing process.
For reasons of hygiene
Even without visible wear, you should replace your FaceFormer regularly, just as you replace your toothbrush from time to time.
Spotting cracks
In our view, small cracks are usually caused by biting on the membrane, not by the training itself. In that case, clear bite marks are usually visible as well. If a crack appears, replace the FaceFormer.
Medical device
Developed in Unna, CE-marked
The FaceFormer is a Class I medical device under the European Medical Device Regulation (MDR) and bears the CE marking. The manufacturer is Dr. Berndsen GmbH in Unna. It was developed by Dr. Klaus-Jürgen Berndsen and Sabine Berndsen at the ISST.
How long does a FaceFormer last?
With regular use, in our experience about six months. If a crack appears before then, usually from biting on it, replace it sooner.
I can taste the FaceFormer
This happens very rarely. The silicone has been tested and is free from harmful substances. Rinse the FaceFormer thoroughly or boil it briefly. If the taste persists, please get in touch with us.
I have a latex allergy
The FaceFormer does not contain latex.
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Knowledge on this topic
Where to go next
Get started
Ready for the training?
The free FaceFormer app guides you through the basic exercises, counts along and reminds you of your sessions. If you wish, a practice from the practitioner directory can support you.
FaceFormer ZERO + ONE
Both material hardnesses for getting started, day and night. The set for adults.
FaceFormer ZERO
The softer FaceFormer for getting started, for children and for the night.
FaceFormer ZERO Children’s Set
ZERO with hygiene box, plush bag and success book with stamp.
FaceFormer training aims to restore the physiological functioning of the basic functions of breathing, swallowing and head balance, with mouth closure and tongue reference position, thereby creating the conditions under which symptoms can improve. It does not replace a medical assessment. You can find practitioners near you in the practitioner directory.