{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "140485", "product_res_number": "Z-0213-2016", "event_date_initiated": "2015-10-07", "event_date_posted": "2015-11-04", "recall_status": "Terminated", "event_date_terminated": "2016-06-14", "res_event_number": "72290", "product_code": "EBC", "k_numbers": [ "K932078" ], "product_description": "Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.", "code_info": "Lot U12511, Kit Lot U19925 (Helioseal F Assortment only), exp. 11.09.2017", "firm_fei_number": "3002808636", "recalling_firm": "Ivoclar A. G.", "address_1": "Fl-9494", "city": "Schaan", "postal_code": "Fl-9494", "country": "Liechtenstein", "additional_info_contact": "Ms. Donna Marie Hartnett, Esq. \n716-691-2260", "reason_for_recall": "A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.", "root_cause_description": "Under Investigation by firm", "action": "Ivoclar Vivadent sent an Urgent Medical Device Recall Letter dated October 7, 2015, with Response Forms via Certified Mail, Return Receipt Requested. Dealers were also contacted via telephone/e-mail and informed to expect the letter. Dealers are requested to check their stock and return any affected material for credit, plus notify their customers of the recall. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825.", "product_quantity": "Domestic: 337 units", "distribution_pattern": "Nationwide Distribution including NJ, PA, SC, FL, IN, IA, WI, IL, MO, TX, CA and WA.", "openfda": { "k_number": [ "K071158", "K802562", "K993846", "K914322", "K963921", "K011491", "K945378", "K991099", "K844308", "K843098", "K232498", "K021842", "K811624", "K810950", "K854494", "K874557", "K924824", "K921600", "K042823", "K062886", "K921599", "K103121", "K961190", "K931857", "K954701", "K874944", "K992516", "K990306", "K891140", "K931869", "K845034", "K790935", "K113818", "K050871", "K110058", "K897027", "K991909", "K111782", "K771327", "K141717", "K012761", "K911287", "K813015", "K093059", "K842392", "K771402", "K874556", "K162598", "K935727", "K061823", "K924635", "K875091", "K914319", "K870579", "K230455", "K951296", "K913853", "K050959", "K760405", "K854882", "K923895", "K843024", "K051224", "K861245", "K992518", "K062344", "K915095", "K012542", "K061997", "K890464", "K102252", "K083473", "K171330", "K902742", "K011822", "K020287", "K091632", "K902022", "K243254", "K800391", "K033751", "K902023", "K802682", "K012742", "K890494", "K932002", "K896341", "K992326", "K932078", "K081493", "K931868", "K260819", "K172169", "K112517", "K161580", "K862695", "K790788", "K011908", "K873069", "K813091", "K801274", "K973541", "K031811", "K991902", "K844211", "K905582", "K990650", "K954867", "K101245", "K862660", "K831380", "K790596", "K954827", "K100062", "K982564", "K952240", "K052281", "K992519", "K130485", "K190998", "K812549", "K053089", "K844057", "K932794", "K965091", "K910813", "K021844", "K190339", "K760418", "K862284", "K122521" ], "device_name": "Sealant, Pit And Fissure, And Conditioner", "medical_specialty_description": "Dental", "regulation_number": "872.3765", "device_class": "2", "registration_number": [ "3042272797", "3012627824", "1450653", "3002789526", "3008912871", "3011430871", "1410097", "3006805063", "1718912", "3012477813", "8020994", "9610902", "3010664129", "3009496224", "2183301", "2133714", "3044819802", "9681356", "8044164", "3014615644", "3012187973", "3004967419", "2027375", "3043226252", "3018507299", "1424442", "1215305", "2523320", "3005176727", "3025307990", "3013584861", "2024980", "2437780", "1281412", "3031841433", "3012996495", "1413475", "9680144", "9680845", "3006444232", "3005665377", "2024312", "3012494290", "1000272892", "3012421607", "1420052", "3000219976", "3018047916", "2424472", "9681254", "2022039", "3006316962", "3004966444", "2244842", "3045857207", "9681210", "3010002722", "3038718579", "1723973", "3010131268", "3045891668", "3006694515", "9612352", "3008966075", "2241860", "2023950", "3016447764", "2511556", "2921595", "3011689956", "2515379", "3007210751", "3006367836", "1013257", "9613953", "3013557697", "3017674095", "9612300", "1000118628", "3042244574", "3013410675", "8010908", "2086043", "1721647", "3004140838", "3032163716", "3003449480", "3002808149" ], "fei_number": [ "3042272797", "3006349398", "3012627824", "1450653", "3002789526", "3001236822", "3008912871", "3011430871", "1410097", "3006805063", "3002808289", "3002807052", "1718912", "3012477813", "3000368601", "3010664129", "3009496224", "2183301", "3044819802", "3002811563", "3014615644", "3012187973", "3004967419", "2027375", "3004150030", "3043226252", "3018507299", "3002088145", "1215305", "2523320", "1000231788", "3005176727", "3025307990", "3005907356", "3002718942", "3013584861", "1281412", "3031841433", "3012996495", "1413475", "3006444232", "3005665377", "3002807166", "2024312", "3012494290", "1000272892", "3012421607", "1420052", "3008875470", "3000219976", "3018047916", "2022039", "3006316962", "3004966444", "3003667632", "3000209941", "2244842", "3045857207", "3010002722", "3038718579", "3001746544", "3010131268", "3045891668", "3002808636", "3006694515", "3000719964", "3008966075", "2241860", "2023950", "3016447764", "2511556", "2921595", "3011689956", "2515379", "3007210751", "3006367836", "1013257", "3013557697", "3017674095", "1000118628", "3042244574", "3002729120", "3013410675", "1721647", "3004140838", "3032163716", "3003449480", "3002808149" ] } } ] }