Decision reached at German Court:
Tooth whiteners are medical devices

Ultradent, a US manufacturer of professional dental bleaching agents won a court trial against the local government of Düsseldorf, Germany.

The local government claimed illegal CE marking: They regard professional bleaching agents as cosmetics. Ultradent convinced the Court, backed by the expert opinion of Dr. Hans Haindl, adviser of MDSS, that the professional bleaching agents must be medical devices.

One of the reasons for basing this decision is that these products do not act upon the body surface (tooth) but rather act in the underlying tissue, in this case the dentine of the tooth. This argumentation has consequences for the classification; the common practice of several manufacturers to classify the bleaching agents as Class 1 will no longer be possible.

The two consequences of the court decision are: