Fresh Recalls

Brand Name: recall status

Notice names this product. Prismatik Dentalcraft’s Brand Name is named in FDA Class II recall Z-2769-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Due to device not having FDA Clearance Identifying 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. Units affected: 20. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Brand Name
Company / brand
Prismatik Dentalcraft
Lot / serial / date codes
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
Distribution
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Agency product description and boundaries

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).

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand
Prismatik Dentalcraft

Recalls naming this model

FDA Class II · Medical device · July 29, 2026

Brand Name recall — Prismatik Dentalcraft, Inc.

Due to device not having FDA Clearance

Company / brand: Prismatik Dentalcraft

Affected product: Brand Name

Official ID Z-2769-2026 · Official record ↗

See all Prismatik Dentalcraft recalls →

Verify with the official sources:

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.