{"url_path":"/fda/device/recalls/Z-2769-2026","section_key":"summary","section_title":"DEVICE Recall: 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 advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-27","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2769-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Prismatik Dentalcraft, Inc."},"word_count":124,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2769-2026\n\n**Recalling firm:** Prismatik Dentalcraft, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-27\n**Report date:** 2026-07-29\n\n## Product\nBrand 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).\n\n## Reason\nDue to device not having FDA Clearance\n\n## Affected lots\nItem 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\n\n## Distribution\nU.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA."}