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

Heraeus Kulzer, LLC

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K130647 XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50MLELW2013-05-17 View
510(k) K123278 IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELFKLE2012-12-07 View
510(k) K120914 FLEXITIME FAST & SCAN LIGHT FLOWELW2012-07-25 View
510(k) K113574 FLEXITIME MONOPHASE PRO SCANELW2012-07-13 View
510(k) K112501 VENUS PEARL PLT REFILL A1EBF2011-12-14 View
510(k) K111832 PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUIDEBI2011-09-29 View
510(k) K110037 PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUIDEBI2011-04-29 View
510(k) K102770 FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOWELW2010-12-21 View
510(k) K101617 FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILLELW2010-09-07 View
510(k) K093575 GLUMA DESENSITIZER POWER GELLBH2010-03-05 View
510(k) K091635 VENUS DIAMOND FLOWEBF2009-09-03 View
↑