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Prismatik Dentalcraft recalls
3 federal recalls on file, showing the 2 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Prismatik Dentalcraft and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-29FDA-DeviceClass IISilent Nite sleep appliance recalled for missing FDA clearance
Prismatik Dentalcraft distributed Silent Nite Sleep Appliances (a mandibular advancement device for snoring and sleep apnea) without obtaining required FDA clearance. The devices were sold in multiple states before the clearance status was identified.
- 2025-11-12FDA-DeviceClass IIBrand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
Incorrect titanium screw, packaged with dental implant.
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