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Prismatik Dentalcraft, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
57
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0417-2026Class IIBrand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.September 30, 2025
Z-1856-2025Class IIGlidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$April 14, 2025
Z-2897-2016Class IIBruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-116August 15, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K254283BruxZir® Shaded 16 PLUSJanuary 30, 2026
K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line ImpNovember 18, 2025
K252446BruxZir® NOWSeptember 3, 2025
K250302Flexible Partial ResinJune 25, 2025
K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical KitMarch 21, 2025
K250223BruxZir® Esthetic NOWFebruary 25, 2025
K241493Glidewell™ 3DP Denture Base ResinSeptember 12, 2024
K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, StraumannJuly 12, 2024
K231940BruxZir® NOW SRCMay 15, 2024
K240882BruxZir® EstheticMay 1, 2024
K240574BruxZir® RadiantMarch 20, 2024
K231529CloudPoint FastDesign ChairsideMarch 14, 2024
K234014Obsidian® NOWFebruary 27, 2024
K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard,November 14, 2023
K233434Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)November 14, 2023
K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered InternSeptember 26, 2023
K231347BruxZir™ TintEFX Coloring LiquidJune 9, 2023
K230262BruxZir™ Incisal Coloring LiquidMay 16, 2023
K223798Glidewell TuffSplint™ Appliance ResinFebruary 17, 2023
K220816BruxZir NOWAugust 2, 2022