Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Kulzer, LLC

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories4
Latest Approval2026-03-11
TypeNumberDevice NameCodeDate
510(k) K260783 Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One EBF 2026-03-11 View
510(k) K254063 iCEM Universal Plus EMA 2025-12-19 View
510(k) K243910 Retraxil MVL 2025-09-24 View
510(k) K240660 Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active EBF 2024-09-17 View
510(k) K233868 dima Print Teeth & Temp EBG 2024-05-23 View
510(k) K230644 Signum opaque F EBF 2023-09-07 View
510(k) K220605 Venus Bulk Flow ONE EBF 2022-04-21 View