Icon
Implants
Icon
Prosthetics
Icon
Biologics
Icon
Instrument
Icon
Custom
Icon
Catalogs
Icon
Education
Icon
Search

Certificates

The Dentium Policy
Dentium USA manufactures quality products based on superior product designs and precision processing techniques to satisfy our customer’s demands and expectations, as well as regional regulatory requirements. We strive for continuous improvements in all we do to ensure we produce and deliver the highest quality products and services.

Certificate
Dentium’s manufacturing facilities, located in Korea and in the USA, are registered establishments with the FDA and certified to ISO 13485:2016. Dentium products are EC Marked to indicate their high quality.

Dentium USA Quality Management System – MDSAP Certificate of Registration – ISO 13485:2016Dentium USA EC Certificate – Full Quality Assurance System, Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding Section 4


If you need a copy of any certificates, please contact us.

Get In Touch