{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219925", "product_res_number": "Z-2769-2026", "event_date_initiated": "2026-04-27", "event_date_posted": "2026-07-21", "recall_status": "Open, Classified", "res_event_number": "98834", "product_code": "LRK", "k_numbers": [ "K183270", "K972424" ], "product_description": "Brand Name: Silent Nite \nProduct Name: Silent Nite Sleep Appliance \nModel/Catalog Number: SILNT \nProduct Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).", "code_info": "Item Number: NITESL\nUDI-DI code: D745SILNT0\nLot/Serial Numbers:\n1020214577\n1020784354\n1030007997\n1030439672\n1030523763\n1030722759\n1106770735\n1107310424\n1107642834\n1108530251\n1110784932\n1117400787\n1118814629\n1121913952\n1122251905\n1122958036\n1124408531\n1125495087\n1127571733\n1131149684", "firm_fei_number": "3011649314", "recalling_firm": "Prismatik Dentalcraft, Inc.", "address_1": "2144 Michelson Dr", "city": "Irvine", "state": "CA", "postal_code": "92612-1304", "additional_info_contact": "Michelle (Shelly) Gallup\n001-949-5339412", "reason_for_recall": "Due to device not having FDA Clearance", "root_cause_description": "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. \n\nCustomers are instructed to:\n1.\tWhat should Customers do with the product?\nFor 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.\n2.\tNotify 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.\n3. 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.\n4. 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.\n5. 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.\n\nFor questions - contact Regulatory Affairs at (949) 836-5479 or email : RA.Mailbox@glidewelldental.com", "product_quantity": "20", "distribution_pattern": "U.S. Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MD, MO, NY, TX, and VA.", "openfda": { "k_number": [ "K926382", "K061688", "K192127", "K240427", "K251628", "K874416", "K051014", "K060744", "K954324", "K140663", "K120371", "K190058", "K060122", "K040417", "K971794", "K183443", "K082849", "K170692", "K991449", "K122475", "K162306", "K022891", "K203477", "K252525", "K103004", "K963591", "K233434", "K113516", "K172760", "K150572", "K232735", "K955822", "K170825", "K022284", "K954128", "K062951", "K182202", "K183270", "K132933", "K050592", "K102463", "K955336", "K121761", "K253845", "K162192", "K142651", "K181123", "K100185", "K152292", "K922984", 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"K234089", "K133390", "K200657", "K131138", "K262104", "K060388", "K150566", "K963063", "K103704", "K112205", "K221889", "K070327", "K111110", "K974531", "K251784", "K223901", "K102118", "K153291", "K093407", "K173064", "K981923", "K250122", "K980952", "K172991", "K033823", "K171316", "K231138", "K252161", "K211069", "K103076", "K160531", "K250353", "K161980", "K252698", "K130558", "K182312", "K153200", "K121285", "K133683", "K150941", "K261134", "K232025", "K261366", "K013049", "K193239", "K210636", "K210203", "K243752", "K090503", "K130067", "K252942", "K073004", "K101155", "K973884", "K083209", "K072731", "K202499", "K021569", "K230947", "K160234", "K222127", "K121344", "K181107", "K210910", "K081965", "K972023", "K214096", "K220688", "K252976", "K895189", "K122391", "K110623", "K222475", "K201719" ], "registration_number": [ "2518422", "3038209294", "3017567754", "3017520337", "3010358861", "3017092365", "3025124", "3025306497", "3030562551", "3013950969", "3000171384", 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"3010852338", "3005730680", "3003928050", "3021841051", "3013652641", "3008583502", "3013548547", "3016674860", "3007496177", "3009495876", "3012728846", "3043364471", "3006786034", "3001295407", "3030914478", "3010767848", "3008102163", "1316408", "3001236549", "3018783197", "3008159012", "3003767844", "3009440973", "3007108578", "3027346720", "3015128224", "3003322666", "3015674959", "3004038575", "3005726841", "1420088", "1937100", "3039643908", "1000118628", "3027579589", "3001003585", "3008808087", "1048735", "3000126629", "3039443708", "3013116677", "3004935484", "3004748290", "3018094310", "3009549313", "1825660", "3005343849", "3012539501", "3013934196", "3002916277", "3002706372", "3006650414", "3017927175", "3006038700", "1045254", "3014680794", "3012359952", "3008763803", "3031282374", "3028271666", "3005598536" ], "device_name": "Device, Anti-Snoring", "medical_specialty_description": "Dental", "regulation_number": "872.5570", "device_class": "2" } } ] }