Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silen
FDA device recall Z-2769-2026 · posted 2026-07-21 · Open, Classified
Recall details
- Recalling firm
- Prismatik Dentalcraft, Inc.
- Reason for recall
- Due to device not having FDA Clearance
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LRK
- Quantity affected
- 20
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
- Date initiated
- 2026-04-27
- Date posted
- 2026-07-21
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Silent Nite sl (K183270) | Prismatik Dentalcraft, Inc. | 2019-07-17 |
| SILENTNITE (K972424) | Glidewell Laboratories | 1997-09-18 |