Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description:…
Prismatik Dentalcraft, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Prismatik Dentalcraft, Inc. · 2144 Michelson Dr · Irvine, CA · 92612-1304
Is this the product you have?
- Brand NameSilent
- Nite Product NameSilent Nite
- Sleep Appliance Model/Catalog NumberSILNT
- Product DescriptionSilent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA)
- Lot codes and dates
- Item NumberNITESL
- UDI-DI codeD745SILNT0
- Lot/Serial Numbers
10202145771020784354103000799710304396721030523763103072275911067707351107310424110764283411085302511110784932111740078711188146291121913952112225190511229580361124408531112549508711275717331131149684
- Amount recalled
- 20
Where it was sold
Why it was recalled
Due to device not having FDA Clearance
This product could cause temporary or reversible health problems — stop using it.
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