XpresSmile’s laboratory is FDA registered and follows guidelines imposed on US dental manufacturers such as QS (Quality System) and cGMP (Current Good Manufacturing Practice) which are the strictest in the industry. Not all cosmetic teeth whitening vendors use FDA registered labs because the registration process is expensive, time consuming and requires the lab to allow regular inspections and to follow strict processes. A gel that is FDA compliant does not mean it comes from an FDA registered lab. All hydrogen peroxide gels under 16% sold to the public are FDA compliant.
Only the very best labs are FDA registered. FDA registration guarantees that XpresSmile products have the same quality, purity, consistency and strength as products used by your dentist. In fact, our lab is a supplier to leading dentists including dental schools like U.C.L.A.
Poorly made gels may have manufacturing impurities or inferior ingredients sourced on the secondary market. XpresSmile products are rigorously tested to confirm they do not contain common microbial contaminants. Every step of the manufacturing process is controlled to FDA standards to ensure all products meet the highest levels of purity.
In order to ensure consistent quality, water used for production is purified to USP standards using a top-of-the-line reverse osmosis system and ultraviolet sterilization. The lab uses jacketed stainless steel mixing and holding vessels as well as jacketed kettles, pumps and filters to ensure a consistent, repeatable process. The lab places a heavy emphasis on quality control at all stages of the manufacturing process. Chemical raw materials are approved for release by Quality Control prior to the transfer to the manufacturing area. Each product batch is inspected at least 4 times- in the mix tank, holding vessel, during packaging and before shipment to our customers.
The entire manufacturing floor has special yellow overhead lighting installed to protect the gels during production and ensure they don’t set or decompose prematurely.
Each batch is then oven tested at extreme temperatures over 3 days to ensure stability and consistency. The gel is then delivered in airtight syringes to ensure a long shelf life. Lab scientists evaluate the effectiveness on real subjects and thoroughly monitor and document their findings. This information is shared with the FDA as part of their ongoing lab inspections.
Finally, XpresSmile’s quality focus extends to the way it is shipped to our customers in special packaging to keep the gels cool and fresh from our facility to your business.
Be sure to select a gel that has the %, lot number, exp date and country of origin listed on the pen or applicator. Without this, you have no gaurantee of the product ingredients, safety, age or origin.
