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Abstract

Manufacturing of custom-made dental devices such as removable dentures, fixed prosthodontics and orthodontics are subject to the requirements of the Medical Devices Directive (MDD). Many dental laboratories often enhance these requirements by implementing quality assurance procedures that then provide enhanced consistency. This paper provided a personal view of some of the systems currently being used in dental laboratories to provide a quality assured product and associated issues.

Keywords

Medicines and Healthcare products Regulatory Agency (MHRA)Medical Devices Directive (MDD)Duty of Candour CAD/CAM Manufacturing Dental Appliances GDC ISO 9001:2008 DAMAS Statement of Manufacture

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References

Care Quality Commission Regulation 20: Duty of candour. Available at: www.cqc.org.uk/content/regulation-20-duty-candour. Accessed: May 2015.

Medicines & Healthcare products Regulatory Agency. Available at: www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about. Accessed May 2015.

Medicines & Healthcare products Regulatory Agency. Public Access Database for Medical Device Registration. Available at: http://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200. Accessed May 2015.

General Dental Council. Guidance on commissioning and manufacturing dental appliances. Available at: www.gdc-uk.org/Dentalprofessionals/Standards/Documents/Guidance%20on%20commissioning%20and%20manufacturing%20dental%20appliances%20(Sept%202013).pdf. Accessed: April 2015.

General Dental Council. Standards for the Dental Team. Available at: www.gdc-uk.org/Newsandpublications/Publications/Publications/Standards%20for%20the%20Dental%20Team.pdf. Accessed: May 2015.

International Organization for Standardization. ISO 9001:2018 Quality management systems – Requirements. Available at: www.iso.org/iso/catalogue_detail?csnumber=46486. Accessed May 2015.

Newsome

. Dental technicians regulation and quality assurance. Br Dent J. 2011;210:25–9. Available at: www.firstlabdirect.co.uk/assets/PDFs/2011/Dental-Technicians-regulation-and-quality-assurance.pdf. Accessed: May 2015.

Dental Appliance Manufacturers Audit Scheme. Available at: www.damas.co.uk. Accessed: May 2015.

GDC.

Crowns, bridges and dentures Do you know what's going in your mouth?

Guidance for patients. Available at: www.gdc-uk.org/Newsandpublications/Publications/Publications/Patients%20Med%20Devices_Layout%203.pdf. Accessed: May 2015.

Credibility and Confidence in Your Dental Laboratory Work – How Quality Assurance Systems Can be Used in the Manufacturing of Individual Custom-Made Dental Devices

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Keywords

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