Concerns about bond strength prompted Bisco Dental Products to issue a recall of its BisCem dual-cured self-adhesive resin cement, according to the FDA recall database.
During product stability testing, Bisco determined that after 15 months of storage, BisCem used in self-cure mode without light curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product components may thicken slightly over time.
The product is intended to serve as a temporary tooth filling or a base cement to affix a temporary tooth filling, crowns, or bridges. It can also be applied to a tooth to protect the pulp. Future production lots will be labeled with a shelf life of one year, with a requirement to refrigerate the product when not in use, according to the company.
