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Kulzer, LLC

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

Total Devices7
Categories4
Latest FDA decision2026-03-11
TypeNumberDevice NameCodeDateActions
510(k) K260783 Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneEBF2026-03-11 View
510(k) K254063 iCEM Universal PlusEMA2025-12-19 View
510(k) K243910 RetraxilMVL2025-09-24 View
510(k) K240660 Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-activeEBF2024-09-17 View
510(k) K233868 dima Print Teeth & TempEBG2024-05-23 View
510(k) K230644 Signum opaque FEBF2023-09-07 View
510(k) K220605 Venus Bulk Flow ONEEBF2022-04-21 View
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