Our Manufacturing & Materials

30+ years of experience servicing dental labs, dentists, and patients globally

• Dental night mouth guards are hand crafted in the U.S. by highly trained dental technicians
• Assembled via time-tested manufacturing and quality control processes
• Manufacturer is FDA registered and compliant with FDA CFR 820 GMP (Good Manufacturing Practices) protocol
• ISO 13485 and 9001 certified

All materials used are 100% FDA approved and registered:

• EVA material (Ethylene-vinyl acetate (also known as EVA) is the copolymer of ethylene and vinyl acetate)
• BPA and latex free
• Non-hazardous or toxic by OSHA per 29 CFR 1910