WARNING – Jyoti Ceramic Industries is a legitimate company in the industry, however their JYODENT® line of zirconia is improperly marketed. JYODENT® is not FDA approved, however ZIECON® (also by Jyoti Ceramic Industries) zirconia discs do have FDA 510(K). We are unsure if JYODENT® discs are in-fact ZIECON®, or if they are an unapproved material. Waiting for response from manufacturer.