⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Prismatik Dentalcraft, Inc.: Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep A

Medical DevicesSource: FDA (device) · Date: 2026-07-29

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Due to device not having FDA Clearance
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Recall initiated
2026-04-27
Code info
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
Product quantity
20
Voluntary mandated
Voluntary: Firm initiated
City
Irvine
State
CA
Country
United States
Event id
98834
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