Class IIOngoingZ-2769-2026
Prismatik Dentalcraft, Inc. recalls Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Num…
Due to device not having FDA Clearance
Prismatik Dentalcraft,…CAJul 29, 2026
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–2 of 2 recalls
Due to device not having FDA Clearance
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.