510(k) K021457 ยท EBG Crown And Bridge, Temporary, Resin
FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL
| Applicant | Pentron Corp., Wallingford CT, US |
| Decision | Substantially Equivalent, Aug 1, 2002 |
| Received | May 6, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2009 | Jeneric/Pentron TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD,
The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent res Terminated |
EBG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.