Oraldent Limited

Oraldent Limited specialises in oral hygiene and protective devices. Its products include interdental brushes, mouth guards for bruxism (teeth grinding), sports mouth guards, and solutions for managing dry mouth symptoms. These devices are designed to support oral health and protection during daily activities or sports.

Oraldent Limited is headquartered in the United Kingdom. The company’s location in the UK influences its regulatory compliance, particularly for devices marketed within the European Economic Area.

Oraldent Limited’s medical devices are listed in the EU’s eudamed database. This registry is used to track Class I devices under the EU Medical Device Regulation (MDR) or the Medical Device Directive (MDD), ensuring transparency for healthcare professionals and authorities.

Oraldent Limited’s devices fall under Class I classification. This classification applies to low-risk products like oral hygiene tools and mouth guards, which typically pose minimal risk to users. Class I devices still require compliance with essential safety and performance requirements but generally undergo less stringent post-market surveillance than higher-risk classes.