There have been recent media reports of lead in dental restorations imported from China. This has raised questions about materials used in the fabrication of dental restorations.
All porcelains manufactured by VITA Zahnfabrik and sold in North America by its subsidiary, VITA North America, fully comply with U.S. Food and Drug Administration (FDA) and Health Canada regulations. VITA porcelains have received premarket clearance after having been found to satisfactorily demonstrate safety and efficacy.
Though VITA product formulas do not include lead, or other harmful substances, minute trace elements well under allowable limits can sometimes be detected. These extremely small inclusions are well within the specifications of the American Dental Association’s ANSI/ADA Specification No. 69 – 1991.
Germany-based VITA Zahnfabrik has been a leading manufacturer of safe and reliable dental restorative materials since 1924 and has sold these products exclusively through VITA North America since 1985. Material Safety Data Sheets (MSDS), safety and efficacy information and additional product facts are available at www.vitanorthamerica.com.
Additional documentation, including FDA device registration numbers, is available upon request by contacting Nevine Erian, Director, Regulatory Affairs & Compliance (Consultant), VITA North America at 800-828-3839 x268.
