Prismatik Dentalcraft, Inc.: Device, Anti-snoring
Prismatik Dentalcraft's Silent Nite Sleep Appliance, a mouthpiece device designed to treat snoring and mild to moderate sleep apnea, is being recalled because it was not cleared by the FDA before being sold. The device was distributed nationwide to patients in multiple states. This is a Class II recall.
- Recalling firm
- Prismatik Dentalcraft, Inc.
- 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).
- Reason
- Due to device not having FDA Clearance
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-27
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e0a7fcb3-9300-4915-ae67-b450964bf449