FDAHealthApril 27, 2026

Prismatik Dentalcraft, Inc. — Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advan

⚠️ Due to device not having FDA Clearance

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 27, 2026

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

What's affected?

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).
Brand: Prismatik Dentalcraft, Inc.
Lot code: /Serial

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 20.

View original FDA notice →

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