FDA Medical Device Recalls (openFDA)
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).
- Recall number
- Z-2769-2026
- Recalling firm
- Prismatik Dentalcraft, Inc.
- Product
- 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).
- Status
- Open, Classified
- Initiated
- 2026-04-27
- Posted
- 2026-07-21
- Terminated
- not on file
- Reason
- Due to device not having FDA Clearance
- Root cause
- Process control
- Action
- 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
- Quantity
- 20
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K183270","K972424"]
- PMA numbers
- not on file
- Product code
- LRK
- Firm FEI
- 3011649314
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28