Indirect laboratory constructed restorations such as an inlay custom made device must be:
- supported by evidence of a laboratory docket or a prescription
- subject to Medical Devices Directive (MDD) regulations
A statement of manufacture must be made available to the patient.
Laboratories must be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA).
Before considering indirect restorations, the General Dental Practitioner (GDP) must:
- address any active disease
- provide an appropriate radiographic assessment
If clinical records were reviewed following a submission of a claim such as an inlay treatment item, the record must include justification for the provision of this indirect restoration.
Indirect restorations such as inlays may be selected to restore moderate to large amounts of tissue destruction. Provision of an indirect restoration such as an inlay for a small cavity is rare, a direct alternative is appropriate.
Practices producing chairside economical restoration of aesthetic ceramic (CEREC) restorations must:
- register with the MHRA
- make sure a statement of manufacture is available to the patient
- make sure it meets the definition of a custom made device
- include the statement ‘...made in accordance with a duly qualified medical practitioner's written prescription’ on the statement of manufacture
Further guidance on Commissioning and Manufacturing Dental Appliances is available on the GDC website.
Guidance notes are available on The National Archives.