Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description:
Summary
The FDA issued a Class II for Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Cata by Prismatik Dentalcraft, Inc.. Reason: Due to device not having FDA Clearance.
Details
Source
Device Recall
External ID
Z-2769-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
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).
Lot/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
Quantity Affected: 20
Reason for Recall
Due to device not having FDA Clearance
Distribution
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-27
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Prismatik Dentalcraft, Inc. has 27 FDA actions in our database, including 3 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Prismatik Dentalcraft, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Prismatik Dentalcraft, Inc. have FDA actions?
Prismatik Dentalcraft, Inc. has 27 FDA actions in our database, including 3 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2769-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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