Indirect, laboratory constructed restorations including an Inlay 'custom made device', must be supported by evidence of a laboratory docket/prescription and are subject to Medical Devices Directive (MDD) regulations. A statement of manufacture must be made available to the patient and laboratories must be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA).
Before considering indirect restorations, it is expected that the general practitioner would have usually addressed any active disease as well as provided appropriate radiographic assessment.
If clinical records were subsequently reviewed following submission of a claim including an Inlay treatment item, then there would be an expectation that the record would include justification for the provision of this indirect restoration including evidence of discussion with the patient regarding any alternative treatment options, including direct restorations.Indirect restorations such as Inlays may be selected to restore moderate to large amounts of tissue destruction. The provision of an indirect restoration, including an Inlay, for a minimally sized cavity would be expected to be relatively rare and a direct alternative generally considered appropriate.
Practices producing Cerec restorations must register with MHRA and, as a 'Manufacturer' of dental appliances/custom made devices, must ensure that a statement of manufacture is available to the patient for whom the dental appliance is made as well as ensuring it meets with the definition of a custom made device which includes "...made in accordance with a duly qualified medical practitioner's written prescription".
Further guidance on Commissioning and Manufacturing Dental Appliances and guidance notes for manufacturers of dental appliances.