Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT
Pending LLM rewrite. Source: FDA_DEVICE Z-2769-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Due to device not having FDA Clearance
The recalled product
- 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
- Prismatik Dentalcraft, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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