Quality Assurance and Regulatory Requirements

Verifying that our products meet all specifications and quality requirements

Quality Assurance is important to us and we have a developed system to verify that our products and services meets the customers meets specifications and requirements of our customers.

Well documented and certificated in accordance with quality standards

Our quality system is well documented and we are certified in accordance with the standards required in the field. We also have the right to CE label our manufactured products in class I, IIa and IIb. We are certified by Intertek to ISO 13485 and EEC/MDD 93/42. We are also registered as manufacturer on many foreign markets, such as e.g. with the FDA in the US and Japanese Minister of Health, Labor and Welfare.

EN ISO 13485 2016

High quality, reliability and safety

Dentatus products are famous for their outstanding quality and reliability. We continuously strive to improve and monitor our product quality.
The regulatory requirements to which we comply with ensures that our products are safe to use and regularly controlled.

Certificates

ISO 13485:2016
EC/MDD 93/42

Registration/accreditation numbers:

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

Download certificates here:

ISO 13485:2016 certificate (PDF)

MDD certificate (PDF)

 

Dentatus

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Dentatus FAQ

Dear Customer, These Are Our Most Frequently Asked Questions

Please see if you can find your answers here, if not, do not hesitate to get in contact with your local distributor office or alternativ...

Dentatus Newsletters

Receive the Latest News from Dentatus Via Our Appreciated Newsletters!

The Dentatus Newsletter is published on a regular basis during the year and if you by any chance have missed ...

General Terms & Conditions

(General Terms & Conditions for the Dentatus Implant Webshop, please click here)

Dentatus’ General Terms & Conditions

It is our policy to make every effort to ...

Quality Assurance and Regulatory Requirements

Verifying that our products meet all specifications and quality requirements

Quality Assurance is important to us and we have a developed system to verify that our products and services meets the c...

The Dentatus Prize

Sweden’s Top Dental Students Receive Prestigious Award

“The Hon. Göran Anneroth Student Achievement Award of the Year” was founded in 1989 by Dentatus owner Prof. Bernard Weissman, together with Pr...

Dentatus History

Swedish Quality in the Global Dental Service

In 2015 Dentatus celebrated their 85th anniversary. Dentatus was founded in Stockholm in 1930 to serve the growing Scandinavian dental market. Today we ...

About Dentatus

Designing innovative dental products
for over 80 years.

Dentatus, known worldwide as a designer of systems and manufacturer of innovative high quality medical devices used in the dental field...