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.
WHITEsmile provides the entire spectrum for a professional bleaching offering in a dental clinic: LIGHT WHITENING, POWER WHITENING, HOME WHITENING and IN-OFFICE WHITENING. That offers a great choice of different treatment methods.
It is our great experience that makes us your competent partner for tooth whitening!
Strategy & Vision
A healthy, white smile is a desire of many people. With its products, WHITEsmile creates optimal opportunities for dental practices to perform the desired tooth whitening on their patients for cosmetic or medical reasons. As a specialist in tooth whitening, WHITEsmile offers dentists and trade partners a perfectly coordinated – product range. Responsible use of resources, respect for employees and customers, trustworthy dealings are the basis of our actions. Our motivated employees manufacture products of outstanding customer benefit.
Our vision: “ We provide the most beautiful, white smile you could wish for.”
Quality Management
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.
MDD/MDR 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 provides proof of the highest quality, reliability and trustworthiness. Annual auditing by the TÜV SÜD PRODUCT SERVICE ensures continual improvement of our quality management system. WHITEsmile products a compliant with ISO 28399:2021 – “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.
