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Ultradent Products, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories7
Latest FDA decision2026-07-01
TypeNumberDevice NameCodeDateActions
510(k) K262228 Transcend Bulk Fill Flowable CompositeEBF2026-07-01 View
510(k) K261404 UltraEZLBH2026-04-30 View
510(k) K240743 Peak Universal BondKLE2024-03-20 View
510(k) K240694 FORMA Composite (Shade A3D)EBF2024-03-15 View
510(k) K221909 J-TempEBF2022-07-01 View
510(k) K220471 VALO X, VALO X Accessory LensesEBZ2022-02-22 View
510(k) K211905 UltraCal XSKIF2021-10-13 View
510(k) K211237 UltraTemp Rez IIEMA2021-07-13 View
510(k) K210550 VALO Grand Corded and Accessory LensesEBZ2021-03-01 View
510(k) K190627 VALO Grand CordedEBZ2019-04-29 View
510(k) K173163 ChlorCid, ChlorCid V, ChlorCid SurfKJJ2018-02-09 View
510(k) K160551 VALO GrandEBZ2016-07-13 View