Dental devices cover a broad spectrum, ranging from implants and instruments to fillers and impression materials. To ensure that the EU Notified Body or UK Approved Body is qualified to review a specific device, devices are categorized and grouped based on the intended use or technologies employed in the device. For the convenience of the manufacturer, we use a single coding system for both the EU and the UK. The devices are allocated codes based on the publicly accessible MDR code list from commission implementation regulation (EU) 2017/2185 of Nov 23, 2017. This is further explained by the Medical Device Coordination Group Document MDCG 2019-14 to identify and categorize dental devices. These may include:
- MDN 1103: non-active dental implants and dental materials, covering devices like dental implants, dental fillers, and permanent root canal guta percha fillers, abutments, dental crowns, veneers and composite resins, among others
- MDN 1202: non-implantable devices designed for the administration, channeling, and removal of substances. It covers items such as the non-active components of suction devices or saliva ejectors, among others
- MDN 1208: this category encompasses non-active, non-implantable instruments such as dental scalers, mirrors, excavators, burnishers and curettes
- MDN 1209: non-active, non-implantable dental materials, such as etching solutions, braces, short-term cements, and impression materials, among others
To support efficient conformity assessments, devices are also grouped using the European Medical Device Nomenclature (EMDN) for the EU, or the Global Medical Device Nomenclature (GMDN) in the UK, to identify and categorize dental devices that can be assessed together.