510(k) K050604 ยท ELW Material, Impression
KERR VPS IMPRESSION MATERIAL
| Applicant | Sybron Dental Specialties, Inc., Orange CA, US |
| Decision | Substantially Equivalent, Apr 15, 2005 |
| Received | Mar 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2012 | Kerr Corporation The brand name of the device is AlgiNot, a dental impression material.
Product Part Numbers
AlgiNot Intra Kit 34683
AlgiNot Volume Refill Terminated |
ELW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.