510(k) K023819 ยท EKM Gutta-Percha
FIBERFILL SGP
| Applicant | Pentron Clinical Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, Mar 26, 2003 |
| Received | Nov 15, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023819
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2009 | Sybronendo Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002 Terminated |
EKM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.