Prismatik Dentalcraft, Inc. recalls Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Num…

Due to device not having FDA Clearance

On 04/27/2026, the firm sent via FedEx an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" Letter to customers informing them that Prismatik discovered that a subset of Silent Nite (Product SKU Number: SILNT, Product ID: NITESL) devices were manufactured using Erkoflex-95, a material not cleared by the FDA for manufacturing the Silent Nite. Customers are instructed to: 1. What should Customers do with the product? For the product listed above, please discontinue use and if you have the product with you, please return it to receive a credit, using the return form attached with the specific contact information to: RA.Mailbox@glidewelldental.com. 2. Notify all relevant personnel within your organization and all patients to whom the affected products may have been prescribed for this recall and the information contained in this letter. 3. When completing the form, indicate the quantities that need to be returned. Please sign, date, and return the form to RA.Mailbox@glidewelldental.com. Keep your quarantine product segregated; our Customer Service Representative will be contacting you with further instructions. 4. Please make a copy of the signed form and place it with the product being returned. This will identify the product as Recall Product for proper handling and disposition. 5. If you do not have product to be returned, place an X next to the statement, No Product to Return , sign, date and return the form to RA.Mailbox@glidewelldental.com. For questions - contact Regulatory Affairs at (949) 836-5479 or email : RA.Mailbox@glidewelldental.com

• FDA enforcement recordOfficial FDA database entry for Z-2769-2026
• FDA 510(k) clearance · K183270The device's official FDA premarket clearance record
• FDA 510(k) clearance · K972424The device's official FDA premarket clearance record
• FDA device classification · LRKOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.5570The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Prismatik Dentalcraft, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.