510(k) K974413 ยท EBF Material, Tooth Shade, Resin
PERMAFLO
| Applicant | Ultradent Products, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Feb 2, 1998 |
| Received | Nov 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974413
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2020 | Ultradent Products, Inc. PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1m average particle size with narrow upper li Terminated |
EBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.