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Kettenbach GmbH & Co. KG

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest FDA decision2025-03-14
TypeNumberDevice NameCodeDateActions
510(k) K250267 Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)EBF2025-03-14 View
510(k) K230333 Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)LBH2023-07-24 View
510(k) K191527 Visalys CemCore, Visalys Cem Core Try In PasteEMA2019-11-08 View
510(k) K191523 Visalys Restorative PrimerKLE2019-10-09 View
510(k) K191524 Visalys Tooth PrimerKLE2019-09-29 View
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