Z-1697-2008

Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is intended to serve as...

Name: Z-1697-2008 Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is intended to serve as...
Creator: Bisco Inc
Published: 2008-04-28
License: https://open.fda.gov/license/

Bisco Inc / initiated 2008-04-28 / Terminated

FDA source

Bisco Inc began a recall of Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is intended to serve as a temporary tooth filling or as a base cement to... on 2008-04-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1697-2008
Status: Terminated
Initiated: 2008-04-28
Posted: 2008-08-25
Terminated: 2010-09-14
Recalling firm: Bisco Inc
Product: Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Opaque; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the pulp.
Product code: EMA Cement, Dental
Reason for recall: 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.
FDA root cause: Incorrect or no expiration date
Action: Bisco sent Urgent Medical Device recall letters dated 4/25/08 to the U.S. consignees via 1st class mail on 4/28/08. The letters informed the users 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. Future production lots will be labeled with a shelf life of 1 year with a requirement to refrigerate the product when not in use. The accounts were requested to destroy their remaining stocks of the product and record the number of used or partially used syringes destroyed, indicating the lot numbers of the units destroyed on the enclosed response form and fax it back to Bisco at 847-534-66101. Questions were directed to Bisco Dental Products Customer Service at 1-800-247-3368.
Distribution: Nationwide including Puerto Rico and internationally to Argentina, Australia, Bulgaria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, Norway, New Zealand, Peru, Philippines, Portugal, Romania, Saudi Arabia, Serbia, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vietnam
Product codes and lots: all lots of Item numbers D-45012P and D-45002S

Product code EMA

K060701Class IIBiscem Translucent, Biscem OpaqueBisco, Inc. / cleared 2006-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)