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

Hazard

Due to device not having FDA Clearance

Details from the source

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. Quantity: 20 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.