Silent Nite Sleep Appliance Recalled Due to Lack of FDA Clearance
Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which according to the rubric corresponds to a Moderate severity level.
Plain-English summary
Prismatik Dentalcraft, Inc. is recalling the Silent Nite Sleep Appliance (Model: SILNT). This mandibular advancement device (MAD) is intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).
The recall was initiated because the device does not have FDA clearance.
This recall affects 20 units distributed nationwide in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
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.
- Hazard
- Affected units
- 20
Distribution
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