In 1994 WHITEsmile was one of the first companies in Europe that specialized in the production of tooth whitening products. Our materials are a result of our own R&D and “Made in Germany”. WHITEsmile materials are clinically tested and certified medical devices.
Strategy & Vision
With WHITEsmile dental clinics have the chance to implement sustainable marketing activities and to create added value. To retailers WHITEsmile is a highly reliable business partner supporting their sales activities with great marketing support.
This makes the WHITEsmile vision more relevant than ever:
“WHITEsmile – Professional Tooth Whitening” the dentists competent business partner for beautiful, white teeth. Highly motivated staff prepares products leading to great customer satisfaction.
Benno Walter, President WHITEsmile GmbH
For WHITEsmile, as one of the leading manufacturers of bleaching materials around the world, a functioning quality management system according to ISO 13485 is essential to economic success. Compliance with international standards is required by our partners and customers. In order to fully meet these requirements, WHITEsmile has implemented a process oriented quality management program, which focuses on our partners and customers.
The directive 93/42/EEC dated June 14, 1993, which pertains to medical devices, serves as the framework of WHITEsmile’s quality management program. All EU member countries are subject to this directive and implementation is enforced by national laws in each country. The directive confronts all manufacturers and distributors of medical devices within the European Economic Area (EU + EFTA) with the same requirements. Certification according to Annex II to the directive 93/42/EEC provides proof of the highest quality, reliability and trustworthiness. Annual auditing by the TÜV Product Service technical inspection agency in Munich ensures continual improvement of our quality management system. WHITEsmile products a compliant with ISO 28399:2011 – “Dentistry – Products for external tooth bleaching” and confirm the excellent quality and safety of our materials.
Classification of Products
Whitening products in the EU with 0.1% to 6% hydrogen peroxide are classified as cosmetics with the cosmetic directive 2011/84/EU starting November 2012 . Whitening products in this concentration can only be used on patients over 18 years and sold only by dentists. With a medical indication whitening products with more than 6% hydrogen peroxide can be further marketed as a medical device. In case of doubt, the national provisions have to be respected. Outside the EU, as before apply the existing rules. WHITEsmile has admission both as a cosmetics manufacturer and a medical device manufacturer.