510(k) K261071 ยท EBF Material, Tooth Shade, Resin
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
| Applicant | DiaDent Group International, Cheongju-Si, KR |
| Decision | Substantially Equivalent, May 19, 2026 |
| Received | Apr 1, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261071
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.