| | Class 2 Device Recall Silent Nite |  |
| Date Initiated by Firm | April 27, 2026 |
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| Date Posted | July 21, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2769-2026 |
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| Recall Event ID |
98834 |
| 510(K)Number | K183270 K972424 |
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| Product Classification |
Device, anti-snoring - Product Code LRK
|
| 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). |
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| Code Information |
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
|
| FEI Number |
3011649314
|
Recalling Firm/
Manufacturer |
Prismatik Dentalcraft, Inc.
2144 Michelson Dr
Irvine CA 92612-1304
|
| For Additional Information Contact | Michelle (Shelly) Gallup
001-949-5339412 |
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Manufacturer Reason
for Recall | Due to device not having FDA Clearance |
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FDA Determined
Cause 2 | Process control |
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| 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
|
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| Quantity in Commerce | 20 |
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| Distribution | U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LRK
510(K)s with Product Code = LRK
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