DenTek Oral Care Limited

DenTek Oral Care Limited specialises in dental repair and protective devices. Their portfolio includes temporary tooth repair kits for minor damage, customisable dental guards (such as night guards), first aid kits for oral emergencies, and adhesive repair materials for dental appliances. These products are designed to address common oral health issues like tooth wear, grinding, and minor trauma.

DenTek Oral Care Limited is headquartered in the United Kingdom. The company’s location in the UK ensures compliance with EU regulatory standards, which govern the design, manufacturing, and distribution of its medical devices.

DenTek Oral Care Limited’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registration is required under the EU Medical Device Regulation (MDR) to demonstrate compliance and traceability for Class I devices.

All of DenTek Oral Care Limited’s devices fall under EU Medical Device Regulation Class I. This classification applies to low-risk products like dental repair kits, temporary fillings, and protective guards, which are deemed to pose minimal risk to patients when used as intended. Class I devices still require compliance with essential safety and performance requirements but typically undergo less stringent post-market surveillance than higher-risk classes.