The FDA has lifted its ban on U.S. imports of Straumann's Biora brand of regeneration products: Emdogain, PrefGel, and Bone Ceramic, the company announced Tuesday.
The FDA had prevented U.S. import of the products after it inspected a Straumann factory in Sweden in October 2006 and found problems with the way the products are made. Straumann has not yet released a date for the products' re-entry into the U.S.
Emogain contains proteins intended to regenerate tissues that attach tooth roots. It is used to treat intrabony defects due to moderate or severe periodontitis, as well as the surgical treatment of gum recessions.
PrefGel is used to remove the smear layer on the tooth surface prior to application of Emdogain. Straumann is now introducing PrefGel in the U.S. in a prefilled syringe.
BoneCeramic is a synthetic bone augmentation material.
