Quality Assurance & Regulatory Requirements

Dentatus thoroughly documents its Quality Assurance System and is certified in accordance with the standards required in the field.

Dentatus is legally allowed to CE label its products in class I and IIa, and is certified by Intertek to ISO 13485:2016 and Regulation (EU) 2017/745 for Medical Devices (MDR).

Dentatus is also registered as a manufacturer in some foreign markets, such as with the FDA in the United States and with the Japanese Minister of Health, Labor and Welfare.

High quality, reliability and safety

Dentatus is known for the quality and reliability of its products and continuously strives to improve them.
Regulatory requirements ensures that Dentatus products are safe to use and regularly controlled.

Certificates

Certificate of Registration ISO 13485:2016 

MDD Extension Confirmation Letter for EU MDR with Product List

Registration and accreditation numbers

US Food and Drug Administration (FDA): 8030870
Japanese Minister of Health, Labor and Welfare: BG20300104