Silent Nite Sleep Appliance recalled — device lacks FDA clearance
Prismatik Dentalcraft distributed Silent Nite Sleep Appliances (a mandibular advancement device for snoring and sleep apnea) without obtaining required FDA clearance. The devices were sold in multiple states before the clearance status was identified.
From the FDA notice · Read the official notice ↗
What to do
- If you own a Silent Nite Sleep Appliance with lot number 1020214577 through 1131149684, contact your dental provider or Prismatik Dentalcraft for instructions.
- Do not discard the device without guidance; your dentist will advise on next steps.
- No injuries have been reported so far.
Is yours affected?
Compare your label or packaging with 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).
- Sold in
- Nationwide
- Made for
- Adults (18 years to 100 years)
Details
- Units affected
- 20
- Illnesses reported
- None reported
- Manufactured in
- 2144 Michelson Dr, N/A, Irvine, CA, United States
- Classification
- Class II
- Recall number
- Z-2769-2026
In the FDA's words
- Description
- 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). Due to device not having FDA Clearance Item Number: NITESL UDI-DI code: D745SILNT0 Lot/Serial Numbers: 1020214577 1020784354 1030007997 1030439672 1030523763 1030722759 1106770735 1107310424 1107642834 1108530251 1110784932 1117400787 1118814629 1121913952 1122251905 1122958036 1124408531 1125495087 1127571733 1131149684 Distribution: U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA. Affected quantity: 20
- Hazard
- Due to device not having FDA Clearance