Xiamen Yizhou Mouth Guard's Compliance with BPA-Free Material Standards
Xiamen Yizhou mouth guard has also been certified BPA-free by an independent, professional company, so for your peace of mind, the materials used to manufacture the mouth guard are quality grade EVA and food grade silicone, which are tested to be safe to your mouth and to your health with no irritations. Intertek's independent, professional testing company, shows that the Bisphenol-A (BPA) that can be found in mouth guards and is considered toxic to your health, has been tested using report No. SZHH01760488 and has been found to be ND (not detected), which is considered to be more than safe according to the California Proposition 65. For the safety of your mouth and body, we use materials that are guaranteed to be non-toxic, non-irritating, and released no non-irritating substances during the mouth guards wear. For everyday use by adults and teenagers, Xiamen Yizhou mouth guards are guaranteed to be safe.
FDA Registration Certification of Xiamen Yizhou's Mouth Guard
The mouth guard application of Xiamen Yizhou has received its FDA registration and thus has been determined to meet the international safety standards. The manufacturer is listed as an over-the-counter dental protector (Device Listing No. D342324) and has FDA facility registration number 3008763803 and operator number 10053196. This registration affirms that the mouth guard meets the safety and quality regulations of the US Medical Device Regulations and therefore grants the mouth guard to be sold and used in North America and in any other country that follows the FDA. The safety of the product is guaranteed with the FDA certification along with the fact that Xiamen Yizhou has met the international quality management system standards.
Support for Xiamen Yizhou's Mouth Guard and ISO 9001 Quality System
Beside FDA certification, Xiamen Yizhou's production management system is certified to ISO 9001:2015, which means they have a systematic way to ensure the safety of products. This certification is about the production of their silicone and plastic products, including the entire mouth guard manufacturing process from sourcing raw materials to delivery of finished goods. Each production link is processed through quality control which includes inspections and records to ensure the product quality is consistent and stable. The product certification and system certification are the double layers of guarantee that ensure Xiamen Yizhou's mouth guard is produced according to international safety and quality standards.
Inspection of Raw Materials from Xiamen Yizhou for Mouth Guards
To eliminate harmful substances like BPA, Xiamen Yizhou implements thorough inspections of all the raw materials the company receives. They have invested in a comprehensive supplier evaluation and management system. They select suppliers that have attribute consistent quality and dependable certifications. All raw materials go through incoming inspections before they can enter production. Inspections look for BPA, heavy metals, and materials that are safe/compatible for the human body. Xiamen Yizhou can track the major raw materials they receive, and inspect all major raw materials, no matter the level of safety risk. This raw materials control system ensures that the mouth guards are free of BPA.
All Mouth Guards from Xiamen Yizhou Are Tested for Safety
To guarantee that the mouth guards from Xiamen Yizhou are FDA Approved and BPA free, the company completes extensive testing for all products, that are produced, in each production run. They not only check for BPA, but they check for lead and other metals, and are in compliance with the testing requirement of the State of California, they check for wear resistance, and they do evaluations of the materials. They conduct random inspections of all the finished products, and any additional inspections that the clients request. The control system for testing ensures that all mouth guards in the control system of testing are not toxic and do not threaten the safety of the mouth holders, in compliance with the regulations of the FDA.
Market Verification and Consumer Recognition of Xiamen Yizhou's Mouth Guard
Market and user feedback has also validated Ecom Yijian’s mouth guard BPA-free and FDA certifications. Businesses and retailers as well as dental institutions have placed bulk orders with Ecom Yijian and there have been zero safety complaints regarding BPA. Customers appreciate the product’s safe and comfortable design and claim it doesn’t irritate the mouth and can be worn for prolonged periods. The mouth guard’s sales in markets where the FDA is the regulatory authority, demonstrate the product’s safety, compliance, and reliability to customers all over the world.
