Regulatory & manufacturer information

Manufacturer

Incydental Ltd (trading as Incydental Dental Laboratory)
Company number 08355880 — registered in England & Wales.
Registered office and place of manufacture:
Unit 12 Devonshire Business Park
74 Eldon Street
Sheffield
S1 4GT
United Kingdom

+44 (0)114 272 1392 · info@incydental.co.uk

Medical device regulation (UK MDR 2002)

Incydental Ltd manufactures custom-made dental devices in accordance with the UK Medical Devices Regulations 2002 (as amended). We are registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a manufacturer of custom-made devices. Our MHRA reference number is available to dental customers on request and is included on the Statement of Manufacture supplied with each device.

Registration with the MHRA does not represent any form of accreditation, certification, approval or endorsement.

Statement of Manufacture

Each custom-made device is supplied with a Statement of Manufacture identifying the prescribing dentist, the patient reference, the device, the materials used and a declaration of conformity with the essential requirements applicable to custom-made devices. Practices must retain this with the patient record.

Materials & traceability

Materials used are CE / UKCA marked for dental use, sourced from approved suppliers. Batch numbers are recorded against each case and retained for a minimum of 11 years to support traceability.

General Dental Council (GDC)

All dental technicians and clinical dental technicians working on cases at Incydental Ltd are registered with the General Dental Council. Registration can be verified at gdc-uk.org.

Reporting adverse incidents

Report any adverse incident involving a device supplied by us to info@incydental.co.uk and to the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk.

Modern slavery & ethical sourcing

We oppose modern slavery and human trafficking in our operations and supply chain, and select suppliers that share these standards.