Home / Recalls / Prismatik Dentalcraft, Inc. / Z-2769-2026

Z-2769-2026 Class II Ongoing

Recalled by Prismatik Dentalcraft, Inc. — Irvine, CA

FDA device recall Z-2769-2026 was initiated by Prismatik Dentalcraft, Inc. on April 27, 2026 and is designated Class II. Reason for recall: Due to device not having FDA Clearance The recall status is ongoing. Affected quantity: 20.

Recall Details

Product Type: Devices
Report Date: July 29, 2026
Initiation Date: April 27, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 20

Product 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).

Reason for Recall

Due to device not having FDA Clearance

Distribution Pattern

U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.

Code Information

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