Prismatik Dentalcraft recalls Silent Nite Sleep Appliance (model SILNT) due to lack of FDA clearance. Consumers should contact the company for details on next steps.
Due to device not having FDA Clearance
Prismatik Dentalcraft is recalling Silent Nite Sleep Appliance models with catalog number SILNT because the device lacks FDA clearance. This means the product has not been approved for safety and effectiveness by the U.S. Food and Drug Administration.
The recall is due to the device not having FDA clearance, which means it has not been proven safe and effective for treating sleep apnea. Without this approval, there is no guarantee the device will work as intended or be safe for use.
People who own or use Silent Nite Sleep Appliance models with catalog number SILNT are affected. Those with sleep apnea or snoring may be at higher risk due to the lack of regulatory approval.
Check for the catalog number SILNT on the product. The affected models include specific lot/serial numbers listed in the recall notice.
Reach out to Prismatik Dentalcraft for information on the recall and next steps.
The product lacks FDA clearance, meaning it has not been approved for safety and effectiveness by the U.S. Food and Drug Administration.
Contact Prismatik Dentalcraft for information on the recall and next steps.
The recall is due to lack of FDA clearance, but the official notice does not specify a risk of injury.
We’ve drafted a message you can send Silent Nite to request your refund or repair — edit it as you like.
Subject: Recall Z-2769-2026 — Silent Nite Silent Nite Hello, I own a Silent Nite that is covered by recall Z-2769-2026 from Silent Nite. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
