Our Manufacturing and Materials
enCore Laboratory has over 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 cleared 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
An additional layer of protection on our impression kits:
- Our impression kits are sealed in tamper-evident, secure packaging for your safety
- Do not use the impression kit if there is evidence of tampering - contact us immediately and we will replace your kit
- Learn more about our clinical trials here
