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Prismatik Dentalcraft, Inc.

FDA 510(k) & PMA Approved Devices — 36 products

Total Devices36
Categories9
Latest FDA decision2026-07-30
TypeNumberDevice NameCodeDateActions
510(k) K262239 Obsidian® Press Over ZirconiaEIH2026-07-30 View
510(k) K254283 BruxZir® Shaded 16 PLUSEIH2026-01-30 View
510(k) K252582 Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant SystemsNHA2025-11-18 View
510(k) K252446 BruxZir® NOWEIH2025-09-03 View
510(k) K250302 Flexible Partial ResinEBI2025-06-25 View
510(k) K242564 Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)KCT2025-03-21 View
510(k) K250223 BruxZir® Esthetic NOWEIH2025-02-25 View
510(k) K241493 Glidewell™ 3DP Denture Base ResinEBI2024-09-12 View
510(k) K240240 Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant SystemsNHA2024-07-12 View
510(k) K231940 BruxZir® NOW SRCNHA2024-05-15 View
510(k) K240882 BruxZir® EstheticEIH2024-05-01 View
510(k) K240574 BruxZir® RadiantEIH2024-03-20 View
510(k) K231529 CloudPoint FastDesign ChairsidePNP2024-03-14 View
510(k) K234014 Obsidian® NOWEIH2024-02-27 View
510(k) K231097 Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant SystemsNHA2023-11-14 View
510(k) K233434 Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)LRK2023-11-14 View
510(k) K223496 Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant SystemsNHA2023-09-26 View
510(k) K231347 BruxZir™ TintEFX Coloring LiquidEIH2023-06-09 View
510(k) K230262 BruxZir™ Incisal Coloring LiquidEIH2023-05-16 View
510(k) K223798 Glidewell TuffSplint™ Appliance ResinMQC2023-02-17 View

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