Sterngold Dental, LLC operates
under a strict quality system which is compliant with the US Food & Drug Administration's
Quality System Regulations and CGMP's. With a continued focus of producing and delivering
superior products and services, Sterngold is EN ISO 13485:2012, ISO 13485:2003 CMDCAS,
MHLW Ministerial Ordinance No. 169 and MDD 93/42-EEC certified. Our alloys are certified
by the American Dental Association (ADA) and produced under the Sterngold Dental,
LLC quality system.
In addition to the United States,
we also have approval to market our products in Canada, Brazil, Colombia, Taiwan,
Europe, Korea, and Japan.
Sterngold Dental LLC's Quality Policy Statement
Provide our customers with consistent, superior product, components, and accessories at competitive prices, on time.
To ensure that our products and services
meet or exceed the requirements of the Quality System guided by EN ISO 13485:2012,
ISO 13485:2003 CMDCAS, MDD 93/42/EEC, MHLW Ministerial Ordinance No. 169 and the
Food and Drug Administration's QSR and Good Manufacturing Practices (GMP). Click
the links below to view certificates.
- ISO 13485:2003
- EN ISO 13485:2012 + AC:2009
- MDD 93/42/EEC
To strive for continued development of the Quality Management System and to meet or exceed all customer expectations.