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Prismatik Dentalcraft, Inc.: Brand Name: Silent Nite Product Name: Silent Nite

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: Due to device not having FDA Clearance. Recalled by Prismatik Dentalcraft, Inc.. Distribution: U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.. Classification (Class II — potential health risk). Affected lots/dates: Item Number: NITESL UDI-DI code: D745SILNT0 Lot/Serial Numbers: 1020214577 1020784354 1030007997 1030439672 1030523763 1. Contact the manufacturer or the retailer where you purchased this device to arrange for a free correction, repair, or replacement.

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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