510(k) K250267 · EBF Material, Tooth Shade, Resin
Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)
| Applicant | Kettenbach GmbH & Co. KG, Eschenburg, DE |
| Decision | Substantially Equivalent, Mar 14, 2025 |
| Received | Jan 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250267
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.