FDA DeviceClass IINotable

FDA Recall: Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT

Date: 2026-07-29
Brand: Prismatik Dentalcraft, Inc.
Category: Medical Device
FDA Class: Class II

Description

Due to device not having FDA Clearance

Hazard

Due to device not having FDA Clearance

Remedy

20

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