Device recall: Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description…
Class II FDA enforcement event 98834. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Due to device not having FDA Clearance
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Prismatik Dentalcraft, Inc. started this device recall on 27 Apr 2026. The firm address in the FDA record is in Irvine, CA. FDA put the recall in Class II. FDA event 98834 has 1 product record. The first FDA enforcement report date is 29 Jul 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
Recalling firm
Prismatik Dentalcraft, Inc., Irvine, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2769-2026 | 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). | 20 | Class II | Ongoing | 29 Jul 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Sep 2025 | Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Mode | Device | Class II | 1 |
| 14 Apr 2025 | Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V | Device | Class II | 1 |
| 15 Aug 2016 | BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2769-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 98834. https://recallregister.com/fda/ii/98834/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
- What quantity of product is in FDA event 98834?
- The FDA record gives this quantity:
20
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.