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Bisco recalls BisCem dental cement

Schaumburg, Ill.—Bisco Dental Products has asked its U.S. and international customers to stop using and dispose of a BisCem dental cement that "may result in reduced bond strength." The company expects to begin shipping the product later this year with a new shelf life and a requirement to refrigerate the product when not in use, a company official said.

The products page on the Bisco Web site describes BisCem as a dual-cured self-adhesive resin cement designed for luting crowns, bridges, inlays, onlays and posts (including prefabricated metal, non-metal/fiber, and cast posts).

The U.S. Food and Drug Administration in a Sept. 3 enforcement report said Bisco initiated the "ongoing" recall by letters dated April 25, 2008. "During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time."

Bisco has notified all customers to cease using the product and dispose of it immediately, said Ted Buckley, director of global sales and marketing. "Bisco has issued public notices to all of its BisCem customers. We have notified every customer by mail and/or telephone who has purchased or has samples of BisCem. We have given a refund or credit to all customers who have purchased BisCem." The company recommends that dentists contact Bisco directly for ongoing and more current information, he said.

Bisco offers a replacement product, Mr. Buckley said.

The Bisco Web site offers this contact information: Bisco, Inc. 1100 W. Irving Park Rd., Schaumburg, IL 60193; sales@bisco.com; toll-free: 1-800-247-3368; ph: 1-847-534-6000.