Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Velmeni with 4 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Jul 23, 2026: VELMENI for DENTISTS (V4D) 3D.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 23, 2026 | VELMENI for DENTISTS (V4D) 3DK254096 · QIH | 510(k) clearances |
| May 11, 2026 | Velmeni for Dentists (V4D) Endo-PerioK252953 · MYN | 510(k) clearances |
| May 11, 2026 | Velmeni for Dentists (V4D) Endo-PerioK252953 · Radiology | AI-enabled devices |
| Sep 2, 2025 | VELMENI for DENTISTS (V4D)K250753 · MYN | 510(k) clearances |
| Sep 2, 2025 | VELMENI for DENTISTS (V4D)K250753 · Radiology | AI-enabled devices |
| Aug 30, 2024 | Velmeni for Dentists (V4D)K240003 · MYN | 510(k) clearances |
| Aug 30, 2024 | Velmeni for Dentists (V4D)K240003 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
