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Prismatik Dentalcraft, Inc. recalls Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description:
Recalled July 29, 2026 · FDA recall Z-2769-2026 · Prismatik Dentalcraft
Hazard
Due to device not having FDA Clearance · FDA Class II
Units
20
Sold at
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Description
Due to device not having FDA Clearance
Product
Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).
Manufacturer(s)
Prismatik Dentalcraft, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →