As these 'machine-produced' crowns or inlays are indirect restorations they're considered to be treatment appropriate to Band 3.

However, as the practice will be providing a 'custom-made device' to patients, to comply with the regulations they also need to be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). More information on this can be viewed in The Medical Devices Regulations (2002).

As well as complying with the procedures described in the MHRAs guidance document, dental laboratories and dental practices constructing their own appliances must be registered with the MHRA with regard to the supply of custom-made medical devices. Where dental practices use computerised CAD CAM milling machines to fabricate their own appliances (crowns, inlays), we understand that some of these machines (e.g. CEREC) are supplied with MHRA registration when installed at the dental practice. However, the responsibility for checking whether or not the practice is registered with the MHRA lies with the practice.