{ "code": "EBZ", "deviceName": "Activator, Ultraviolet, For Polymerization", "deviceClass": "II", "regulationNumber": "872.6070", "panel": "Dental", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 214, "last12Months": 2 }, "adverseEvents": { "total": 12, "last12Months": 2 }, "reviewDays": { "median": 65, "sampleSize": 214 }, "recalls": { "total": 4, "recent": [ { "resNumber": "Z-0746-2022", "status": "Open, Classified", "recallClass": "Class II", "firm": "Envisiontec US Llc", "firmAsPublished": "Envisiontec US Llc", "reason": "The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.", "initiated": "2022-01-20" }, { "resNumber": "Z-0797-2019", "status": "Open, Classified", "recallClass": "Class II", "firm": "Handpiece Headquarters", "firmAsPublished": "Handpiece Headquarters", "reason": "Tip of the curing light was too hot causing a heat sensation in the patients.", "initiated": "2018-04-04" }, { "resNumber": "Z-1740-2014", "status": "Terminated", "recallClass": "Class II", "firm": "Ivoclar Vivadent, Inc.", "firmAsPublished": "Ivoclar Vivadent, Inc.", "reason": "A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.", "initiated": "2014-04-14" }, { "resNumber": "Z-1505-2012", "status": "Terminated", "recallClass": null, "firm": "O'Ryan Industries Inc", "firmAsPublished": "O'Ryan Industries Inc", "reason": "Disposa-Shield Disposable Curing Shield is recalled due to lacking 510K, PMA or IDE, and inadequate quality system.", "initiated": "2012-04-23" } ] }, "recentClearances": [ { "kNumber": "K253131", "deviceName": "Curing Light (M-Cure 6)", "applicant": "Guangzhou Rebornendo Medical Instrument Co., Ltd.", "company": "Guangzhou Rebornendo Medical Instrument Co., Ltd.", "decisionDate": "2026-06-18", "dateReceived": "2025-09-25" }, { "kNumber": "K253461", "deviceName": "Demi Pro", "applicant": "Meta Systems Co., Ltd.", "company": "Meta Systems Co., Ltd.", "decisionDate": "2025-10-14", "dateReceived": "2025-10-07" }, { "kNumber": "K242386", "deviceName": "Bluemoon", "applicant": "Genoss Co., Ltd.", "company": "Genoss Co., Ltd.", "decisionDate": "2025-05-05", "dateReceived": "2024-08-12" }, { "kNumber": "K243921", "deviceName": "LED Curing Lights (DB686 HALO)", "applicant": "Foshan Coxo Medical Instrument Co., Ltd.", "company": "Foshan Coxo Medical Instrument Co., Ltd.", "decisionDate": "2025-04-11", "dateReceived": "2024-12-20" }, { "kNumber": "K250009", "deviceName": "LED Curing Light (C01-X, C02-X)", "applicant": "Premium Plus (Dongguan) Limited", "company": "Premium Plus (Dongguan) Limited", "decisionDate": "2025-04-10", "dateReceived": "2025-01-02" }, { "kNumber": "K241238", "deviceName": "LOOP™ LED Curing Light System (CLK01)", "applicant": "Garrison Dental Solutions, LLC", "company": "Garrison Dental Solutions, LLC", "decisionDate": "2024-08-01", "dateReceived": "2024-05-03" }, { "kNumber": "K223414", "deviceName": "Curing Light, Model: MaxCure 9", "applicant": "Guilin Refine Medical Instrument Co., Ltd.", "company": "Guilin Refine Medical Instrument Co., Ltd.", "decisionDate": "2023-11-15", "dateReceived": "2022-11-10" }, { "kNumber": "K233518", "deviceName": "BASE290 LED Curing Light", "applicant": "Handpiece Headquarters", "company": "Handpiece Headquarters", "decisionDate": "2023-11-02", "dateReceived": "2023-11-01" }, { "kNumber": "K223507", "deviceName": "CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)", "applicant": "Good Doctors Co., Ltd.", "company": "Good Doctors Co., Ltd.", "decisionDate": "2023-08-04", "dateReceived": "2022-11-22" }, { "kNumber": "K223142", "deviceName": "Coltolux Comfort LED Curing Light", "applicant": "Dent4you AG", "company": "Dent4you AG", "decisionDate": "2022-12-22", "dateReceived": "2022-10-04" } ], "topApplicants": [ { "name": "Monitex Industrial Co., Ltd.", "count": 9 }, { "name": "Rolence Enterprise Co. , Ltd.", "count": 8 }, { "name": "Ultradent Products, Inc.", "count": 7 }, { "name": "Ivoclar Vivadent, Inc.", "count": 6 }, { "name": "Dentsply Intl.", "count": 5 } ], "topCompanies": [ { "name": "Monitex Industrial Co., Ltd.", "count": 9, "spellings": 1 }, { "name": "Ivoclar Vivadent, Inc.", "count": 8, "spellings": 2 }, { "name": "Rolence Enterprise Co. , Ltd.", "count": 8, "spellings": 1 }, { "name": "Ultradent Products, Inc.", "count": 7, "spellings": 1 }, { "name": "Kerr Corporation", "count": 6, "spellings": 2 } ], "newEntrants": [ { "name": "Guangzhou Rebornendo Medical Instrument Co., Ltd.", "since": "2026-06-18", "kNumber": "K253131" }, { "name": "Meta Systems Co., Ltd.", "since": "2025-10-14", "kNumber": "K253461" } ], "baseline": { "months": [ { "month": "2023-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-09-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "EBZ (Activator, Ultraviolet, For Polymerization) has two findings, most consequential first. 2 first-time filers in the last 12 months, Guangzhou Rebornendo Medical Instrument Co., Ltd. and Meta Systems Co., Ltd (K253131, K253461). The code is crowded, scoring 73 of 100 — 120 companies hold a clearance here and 2 arrived in the last 12 months (EBZ:crowding).", "severity": 42, "factors": [ { "kind": "new_entrant", "detail": "2 first-time filers in the last 12 months, Guangzhou Rebornendo Medical Instrument Co., Ltd. and Meta Systems Co., Ltd.", "recordIds": [ "K253131", "K253461" ], "severity": 42 }, { "kind": "crowding", "detail": "the code is crowded, scoring 73 of 100 — 120 companies hold a clearance here and 2 arrived in the last 12 months", "recordIds": [ "EBZ:crowding" ], "severity": 20 } ], "sourcesChecked": [ "predicate ancestry", "recalls", "adverse events", "new entrants", "review time", "crowding" ] }, "predicatePreview": { "edges": [], "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet." }, "sources": [ { "label": "classification", "url": "https://api.fda.gov/device/classification.json?search=product_code%3AEBZ" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEBZ" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEBZ" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEBZ" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEBZ" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEBZ" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEBZ" } ], "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51, "exportDate": "2026-08-08" }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2, "exportDate": "2026-08-08" }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53, "exportDate": "2026-08-04" }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:49:57Z", "ingestRun": 73, "exportDate": "2026-08-11" }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52, "exportDate": "2026-08-08" }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10, "exportDate": "2026-08-08" } ], "retrievedAt": "2026-08-11T13:51:45.690Z" }