Regulatory Information

Please check the label of your etkon iDent product. The CE mark (CE0123) indicates that the product is in compliance with all applicable Essential Requirements as stipulated by the European Medical Device Directive 93/42/EEC.

In cases where the product label does not bear a CE-mark, it is labeled as a custom-made device. Some of the design features of a custom-made device fall under the responsibility of the orderer. In these situations, it is impossible for etkon to evaluate the compliance with all Essential Requirements of the Directive 93/42/EEC. The following declaration according to annex VIII of EU Directive 93/42/EEC applies to the custom-made dental restorations:

etkon GmbH herein confirms that the custom-made dental restorations were manufactured according to the data and information supplied by the orderer. The dental restorations are intended to be used solely for the patient intended by the orderer. The dental restorations meet the applicable Essential Requirements according to annex I of EU Directive 93/42/EEC as far as indicated in etkon's statement of Essential Requirements