In the course of a routine inspection of Biora AB, Straumann`s oral regenerative product company in Sweden, in October 2006, a U.S. Food and Drug Administration (FDA) investigator made a number of observations predominantly concerning maintenance of quality system documentation and procedures associated with the company`s products. Biora has received a ``warning letter`` from the FDA, which indicated that its ``dental bone grafting materials`` are on import detention in the U.S., until the inspectional observations are resolved. No other countries apart from the U.S. are affected. The products concerned are: Straumann BoneCeramic, Emdogain, and PrefGel.

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