Z-2769-2026Class II

Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product...

Name: Z-2769-2026 Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product...
Creator: Prismatik Dentalcraft, Inc.
Published: 2026-04-27
License: https://open.fda.gov/license/

Prismatik Dentalcraft, Inc. / initiated 2026-04-27 / Open, Classified / root cause: manufacturing process

FDA source

Prismatik Dentalcraft, Inc. began a recall of Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular... on 2026-04-27. FDA classified it as Class II and gives the reason as "Due to device not having FDA Clearance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2769-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-27
Posted: 2026-07-21
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).
Product code: LRK Device, Anti-Snoring
Reason for recall: Due to device not having FDA Clearance
Root cause tag: manufacturing process
FDA 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: [email protected]. 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 [email protected]. 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 [email protected]. For questions - contact Regulatory Affairs at (949) 836-5479 or email : [email protected]
Quantity in commerce: 20
Distribution: U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2769-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2769-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-21

Product code LRK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)