WHITEsmile GmbH

WHITEsmile GmbH specializes in professional dental whitening devices. Their portfolio includes tooth whitening gels like the Power Whitening YF 40% HP and Light Whitening AC 32% HP, as well as systems such as the fläsh 32% HP whitening kit and fläsh Lip Retractor. They also produce the Gingiva Protector for gum protection and Curaden CURASEPT WHITE 38%, which is designed for professional dental whitening procedures. All products are intended exclusively for use in dental practices.

WHITEsmile GmbH is based in Germany. Their devices are developed and marketed in compliance with the EU Medical Device Regulations (MDR), ensuring they meet the necessary safety, performance, and regulatory standards for professional dental applications. The company adheres to these requirements to ensure their products are suitable for use in dental practices.

WHITEsmile GmbH’s devices are registered in the EU’s eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and traceability of their products under the EU Medical Device Regulations, allowing healthcare professionals and regulators to verify their compliance and classification.

WHITEsmile GmbH’s devices are classified as either Class I or Class IIa under the EU Medical Device Regulations. The classification is determined by factors such as the intended use, risk associated with the device, and its interaction with the body. For example, whitening gels and protectors like the Gingiva Protector are typically lower-risk and fall under Class I, while some whitening systems or higher-risk applications may be classified as Class IIa due to their potential effects on oral tissues.