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).

Class II

Recalling firm: Prismatik Dentalcraft, Inc.
Reason for recall: Due to device not having FDA Clearance
Affected products (lot / model / serial): 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
Units affected: 20
Distribution pattern: U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Firm location: Irvine, CA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: N/A
Product type: Devices
Status: Ongoing
Recall number: Z-2769-2026
Recall initiated: April 27, 2026
FDA classification date: July 21, 2026
FDA report date: July 29, 2026
FDA event ID: 98834
Last updated on HTM Vibe: August 4, 2026