510(k) K060701 ยท EMA Cement, Dental
BISCEM TRANSLUCENT, BISCEM OPAQUE
| Applicant | Bisco, Inc., Schaumburg IL, US |
| Decision | Substantially Equivalent, May 15, 2006 |
| Received | Mar 16, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060701
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2008 | Bisco Inc Dental Cement-Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement, Translucent; The product is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to Terminated |
EMA | None listed |
| Aug 25, 2008 | Bisco Inc 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 Terminated |
EMA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.