Medical Device

Eq. Training Eptamed

Package Insert – Instructions for Use

Training

General Information

Please read the following instructions carefully before using the product.

Failure to follow the safety and storage instructions may pose risks to health and the environment.

Intended Use

The Eptamed Eq. Training device is a non-sterile medical device intended for the treatment of disorders of the lower jaw and oromasticatory function.

Warnings

The Eptamed Eq. Training device was prescribed to you by your dentist. Carefully follow all the instructions and exercises recommended to you in order to achieve the best possible results in the shortest possible time.

  • Before use, make sure you do not have any known allergies or hypersensitivities to the materials used in Eq. Eptamed.
  • If you experience an allergic reaction, stop using the product and contact your dentist.
  • Biting down too hard on the Eq. Training Eptamed may cause the product to break partially or completely. If this happens, stop using it and consult your dentist.
  • When disposing of the Eq. Eptamed, the applicable legal regulations regarding waste disposal must be strictly observed.
  • Any serious incident involving the Eq. Eptamed must be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is based or resides.

Instructions for Use

Before placing the Eptamed exercise device between the dental arches, remove it from its storage case and perform the exercise recommended by your healthcare professional based on your specific condition.

If you experience any discomfort, such as pain, inflammation, or swelling of the gums, while using this product, stop using it and consult your healthcare provider.

Application

The duration and method of use are determined by the treating professional. As a general rule, the Eq. Training Eptamed should be used for at least 1 hour each day during the daytime.

The exercises using the Eptamed devices are available in the MyEptamed app, which can be downloaded to your smartphone.

Age of Use

The Eptamed Eq. Training program can be used by children ages 5 and up.

Contraindications

The use of the Eptamed Equilibrium Trainer should be carefully considered in cases of loose teeth, advanced periodontitis, pain in the temporomandibular joint, or dental implants.

Always consult your healthcare provider before use.

Care and Cleaning

The Eptamed Eq. Training device must be rinsed under running water after each use. If necessary, a special cleaning agent such as EptaClean may be used.

If necessary, carefully remove any saliva residue with a toothbrush.

Dry the Eq. Training Eptamed by gently patting it with an absorbent cloth or a clean towel. Then let it air dry completely before storing it in its storage case.

Color changes do not affect the functionality of the Eq. Eptamed.

Exchange Criteria

The treating professional decides whether and when the Eq. Training Eptamed needs to be replaced.

In general, it is recommended to replace the Eq. Eptamed once a predetermined treatment goal has been achieved. Replacement of the Eq. Eptamed is recommended if structural changes caused by chewing could impair its function.

Storage

Store Eq. Training Eptamed in a dry, clean place, away from heat sources and direct sunlight.

Avoid contact with citrus fruits and essential oils, as they may cause Eq. Eptamed to discolor.

Keep out of reach of pets.

Always store the medical device under appropriate hygienic conditions.

Materials Used

The Eptamed Eq. Training is made of a biocompatible, polypropylene-based thermoplastic material.

Manufacturer Information and Symbols

Eptamed Srl
Via Luciano Lama 101
47521 Cesena (FC) ITALY
Tel. +39 0547 483800
www.eptamed.com

Symbol text in English: identical to the original PDF, including the German version.

Publication Date: September 2026

Explanation of Symbols

Simbolo fabbricante 3

Manufacturer

Qty

Quantity

Non-sterile medical device

Udi

UDI – Unique Device Identifier

Lot

LOT – Batch code

Simbolo ref 3

REF – Catalog Number

Md

MD – medical device

Info

Please refer to the instructions for use

Ce

CE Marking

Download the original package insert

German version of the official Eptamed instructions for use. Note: The original document does not have a separate “Exercises” section—the information about the MyEptamed app is included in the “Usage” section.

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