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Prismatik Dentalcraft Recalls
4 recalls on record · October 5, 2016 to July 29, 2026 · Medical Devices
Recalls by year
16
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 29, 2026Medical DevicesFDA
Prismatik Dentalcraft, Inc. recalls Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description:
Hazard: Due to device not having FDA Clearance
November 12, 2025Medical DevicesFDA
Prismatik Dentalcraft, Inc. recalls Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Mo
Hazard: Incorrect titanium screw, packaged with dental implant.
June 4, 2025Medical DevicesFDA
Prismatik Dentalcraft, Inc. recalls Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219
Hazard: Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
October 5, 2016Medical DevicesFDA
Prismatik Dentalcraft, Inc recalls BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The de
Hazard: Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.