510(k) K072545 ยท EBF Material, Tooth Shade, Resin
ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
| Applicant | Pentron Clinical Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, Oct 26, 2007 |
| Received | Sep 10, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2012 | Kerr Corporation Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC.
Product Usage:
The intended use of this device is as a self-etch, self-adhesive flowable resin composite indicated for light-cured dental r Terminated |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.