CE certification
Our CE certified materials
Our main materials, Eldy Plus, Dentalos Plus, Polyan Plus and Flexistrong Plus, are CE certified. This means that they meet the legal requirements and guarantee the safety and health of patients.
However, there are auxiliaries in dental technology which are required for bonding with other materials, such as liquids like adhesives, bonders or similar. For these, the letter from the specialist lawyer is intended to clarify that materials can be CE certified but do not HAVE to be.
This is the current status of the German jurisdiction.
The dental technician as a special medical manufacturer
The fact is, the dental technician is a special medical manufacturer and, based on his extensive training, can produce a dental prosthesis from a wide variety of materials, which automatically becomes a 2A product at the end and can therefore remain in the mouth for longer than 30 days.
The dental technician should only ensure that the final product does not pose any direct or indirect risk to the patient.
Therefore, every manufacturer of aids is obliged to test his materials for toxicity or allergenic ingredients, but this is independent of the application of a CE mark.
In the background, we have for all our aids, the corresponding tests which we make available to any dental technician in a possible legal case.
If you have any questions, please do not hesitate to contact us.
Things to know about certification
- to class I if they are intended for temporary use,
- are in class IIa if they are intended for short-term use, unless they are used in the oral cavity as far as the pharynx, in the ear canal as far as the eardrum or in the nasal cavity, in which case they are in class I, and
- Class IIb if they are intended for long-term use, unless they are used in the oral cavity as far as the pharynx, in the auditory canal as far as the tympanic membrane or in the nasal cavity and they cannot be absorbed by the mucosa, in which case they are in Class IIa.
