Diamond D Ultra Impact Denture Acrylic is the premium denture polymer proven to meet ADA/ANSI Specification #12 requirements for Denture Base Polymers. Diamond D High Impact Denture Acrylic received their 510(k) NO: K032773 on 09/23/03. It is manufactured by Keystone Industries in their cGMP, ISO 9001:2000 and ISO 13485:2003 compliant facility located in Cherry Hill, New Jersey USA. Not all Hi-Impact Denture Acrylics are manufactured in ISO compliant facilities, is yours? Ask for documentation. - April 08, 2008