From the beginning, EZ-Pedo's ultimate goal was to bring you the best
product possible. Quality is the foundation of our goal and the premise
that inspired our quest to obtain the recognition of the world's
most recognized certifying bodies.
EZ-Pedo Zirconia crowns have been FDA cleared as a safe and effective medical device since 2009. Receiving 510(k) clearance is an important status as it demonstrates our desire to meet and exceed all regulatory requirements in the USA and around the globe.
FDA 510(k) clearance does not imply FDA approval. However, it is a matter of historical record that EZ-Pedo was the first company to manufacture prefabricated pediatric Zirconia crowns and obtain clearance to market them in the United States. Because EZ-Pedo was the first company to manufacture and sell Zirconia crowns for children in the United States, we are the only company that was required to complete a 510(k) application. EZ-Pedo pioneered a technology that has been adopted in the USA and around the world and has dramatically changed the face of pediatric dentistry —forever.
What is ISO 13485?
EZ-Pedo is proud to be one of the few dental laboratories in the USA that carry the ISO 13485 certification.
ISO 13485 is the international quality standard for medical device manufacturers. Yes, EZ-Pedo Zirconia crowns are in fact classified as medical devices!
ISO-certified manufacturers must first submit an application, and then pass an extensive multi-level audit performed by an internationally recognized auditor each year. Not only must each step of the manufacturing process meet strict quality standards, but other factors that ensure a quality product-such as design, customer feedback, continuous improvement, and adherence to clean manufacturing practices-are all held to the same strict guidelines.
All raw materials that go into EZ-Pedo Zirconia crowns (including Zirconia and glazes) are required to demonstrate proof of ISO compliance as well.
Knowing that EZ-Pedo meets such strict quality control standards, you can rest assured that only the safest materials of highest quality are used in the production of EZ-Pedo Zirconia crowns.
What is the CE mark?
EZ-Pedo Zirconia crowns carry the CE mark. This means that EZ-Pedo Zirconia crowns are licensed and approved for sale throughout the European Union. Since EZ-Pedo Zirconia crowns are considered a Class II medical device by the European Council on Medical Devices, compliance requires an audit similar to ISO 13485 to demonstrate that EZ-Pedo adheres to strict safety and quality standards.
To be sold in Australia, all medical devices must have an approval from the Therapeutic Goods Administration (TGA). The TGA is a regulatory authority governing the sale of medical devices and its goal is to provide Australians with confidence in the safety and quality performance of imported devices.
EZ-Pedo is approved by the TGA and carries the Australian Register of Therapeutic Goods Certificate.
All medical devices must have a license from the Canadian Health Ministry to be sold in Canada.
Health Canada has very strict regulations detailing the quality, safety and efficacy that must be demonstrated before a license will be granted. Unlike the FDA and the European Council, which do not require ISO 13485 certification, Health Canada not only requires it, but has additional requirements which exceed the International ISO 13485 standard.
EZ-Pedo has been awarded both the International ISO 13485 standard and the Health Canada ISO 13485 standard certifications. EZ-Pedo was the first prefabricated pediatric Zirconia crown manufacturer in the world with a Health Canada license.
EZ-Pedo is committed to helping our dentists be successful when using
EZ-Pedo crowns. That's why we've developed hands-on pediatric
workshops designed just for you. Learn new skills and techniques
needed to be successful every time you use an EZ-Pedo crown.