Celebrating its centennial in 2025, The Hygenic Company traces its roots to a 1925 Akron manufacturer of vulcanized rubber dentures and has remained closely tied to the dental market ever since. Today, the company develops custom elastomer components for manufacturers, with products made in U.S. and Asian facilities that operate under ISO 13485:2016-certified quality systems.
ISO 13485:2016 Quality Management System
FDA Registered Manufacturing Locations
Registration
UDI Compliant
Registration
21 CFR 177.2600 Food-Contact Compliance
Compliance program
GRAS Part 182 and 21 CFR Part 172
Compliance program
FDAREGISTRATION
Quality certification