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