# FDA recall Z-2769-2026

> **Prismatik Dentalcraft, Inc.** · Class II · device recall initiated 2026-04-27.

## 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 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.

## Key facts

- **Recall number:** Z-2769-2026
- **Recalling firm:** Prismatik Dentalcraft, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-27
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2769-2026

## Citation

> AI Analytics. FDA recall Z-2769-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2769-2026. Source: US FDA. Licensed CC0.

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