510(k) K010940 ยท KIF Resin, Root Canal Filling
SEALAPEX 4
| Applicant | Sybron Dental Specialties, Inc., Orange CA, US |
| Decision | Substantially Equivalent, Jun 20, 2001 |
| Received | Mar 29, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010940
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2016 | Ormco/Sybronendo Sealapex Xpress, Part No. 33639
The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of Terminated |
KIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.