Legal & Compliance

MHRA Registration

SINTEO is registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a manufacturer of custom-made dental devices.
Our registration covers fixed, removable, implant and temporary prosthetics under the relevant GMDN/EMDN categories.

Quality Management System

• Compliance with ISO 13485
• Risk Management according to ISO 14971
• Document & Record control (10 years retention)

Regulated Product Categories

List of products (GMDN / EMDN)

• Fixed dental prostheses (Zirconia, CoCr, PMMA,…)
• Temporary dental prostheses
• Implant abutments
• Combined prosthetics
• Surgical guides
• etc.

UK Responsible Person

ADVENA Ltd UK
Pure Offices
Plato Close
Warwick CV34 6WE
United Kingdom

T: +44 1926 800 153

E: info@advenamedical.com

Registered in England and Wales 3517275
VAT NO. GB 702 5900 65

Our appointed UK Responsible Person (UKRP) ensures regulatory compliance within the United Kingdom, including PMS, vigilance and documentation oversight.