{ "code": "EBG", "deviceName": "Crown And Bridge, Temporary, Resin", "deviceClass": "II", "regulationNumber": "872.3770", "panel": "Dental", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 189, "last12Months": 2 }, "adverseEvents": { "total": 1, "last12Months": 0 }, "reviewDays": { "median": 86, "sampleSize": 189 }, "recalls": { "total": 4, "recent": [ { "resNumber": "Z-0512-2021", "status": "Terminated", "recallClass": "Class III", "firm": "Talladium Inc", "firmAsPublished": "Talladium Inc", "reason": "Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation.", "initiated": "2020-10-09" }, { "resNumber": "Z-0482-2010", "status": "Terminated", "recallClass": null, "firm": "Jeneric/Pentron, Inc.", "firmAsPublished": "Jeneric/Pentron", "reason": "Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting.\nInvestigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.", "initiated": "2009-10-22" }, { "resNumber": "Z-1041-04", "status": "Terminated", "recallClass": null, "firm": "Lang Dental Mfg. Co., Inc.", "firmAsPublished": "Lang Dental Mfg Co, Inc.", "reason": "The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.", "initiated": "2004-06-07" }, { "resNumber": "Z-1042-04", "status": "Terminated", "recallClass": null, "firm": "Lang Dental Mfg. Co., Inc.", "firmAsPublished": "Lang Dental Mfg Co, Inc.", "reason": "The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.", "initiated": "2004-06-07" } ] }, "recentClearances": [ { "kNumber": "K261261", "deviceName": "Dura-Arch", "applicant": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "company": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "decisionDate": "2026-04-17", "dateReceived": "2026-04-16" }, { "kNumber": "K253380", "deviceName": "“FLNT Base” and “FLNT Temp”", "applicant": "Liaoning Upcera Co., Ltd.", "company": "Liaoning Upcera Co., Ltd.", "decisionDate": "2026-03-02", "dateReceived": "2025-09-30" }, { "kNumber": "K251271", "deviceName": "TempFIT Temporary Crown and Bridge Resin", "applicant": "Rizhao Huge Biomaterials Company, Ltd.", "company": "Rizhao Huge Biomaterials Company, Ltd.", "decisionDate": "2025-06-23", "dateReceived": "2025-04-24" }, { "kNumber": "K243370", "deviceName": "DentaTOOTH", "applicant": "Asiga Pty, Ltd.", "company": "Asiga Pty, Ltd.", "decisionDate": "2025-05-05", "dateReceived": "2024-10-30" }, { "kNumber": "K243621", "deviceName": "Evoblock, Perléon", "applicant": "Evoden Indústria Comércio Importação E Exportação", "company": "Evoden Indústria Comércio Importação E Exportação", "decisionDate": "2025-04-22", "dateReceived": "2024-11-22" }, { "kNumber": "K243951", "deviceName": "TEMP MASTER, PMMA-based dental resin", "applicant": "Taiwan Dental Materials Co., Ltd.", "company": "Taiwan Dental Materials Co., Ltd.", "decisionDate": "2025-02-21", "dateReceived": "2024-12-23" }, { "kNumber": "K242559", "deviceName": "Digital Temp", "applicant": "Sprintray, Inc.", "company": "Sprintray, Inc.", "decisionDate": "2024-11-26", "dateReceived": "2024-08-28" }, { "kNumber": "K231859", "deviceName": "PrimmaArt", "applicant": "Dentscare Ltda", "company": "Dentscare Ltda", "decisionDate": "2024-11-26", "dateReceived": "2023-06-23" }, { "kNumber": "K240538", "deviceName": "Premium Teeth Resin", "applicant": "Formlabs Ohio, Inc.", "company": "Formlabs Ohio, Inc.", "decisionDate": "2024-07-19", "dateReceived": "2024-02-26" }, { "kNumber": "K241226", "deviceName": "Fixtemp® C&B 4:1", "applicant": "Dreve Denatmid GmbH", "company": "Dreve Denatmid GmbH", "decisionDate": "2024-05-31", "dateReceived": "2024-05-02" } ], "topApplicants": [ { "name": "GC America, Inc.", "count": 6 }, { "name": "Ivoclar Vivadent, Inc.", "count": 6 }, { "name": "Sybron Dental Specialties, Inc.", "count": 6 }, { "name": "Dmg USA, Inc.", "count": 5 }, { "name": "Voco GmbH", "count": 5 } ], "topCompanies": [ { "name": "GC America, Inc.", "count": 6, "spellings": 1 }, { "name": "Ivoclar Vivadent, Inc.", "count": 6, "spellings": 1 }, { "name": "Sybron Dental Specialties", "count": 6, "spellings": 1 }, { "name": "Dmg USA, Inc.", "count": 5, "spellings": 1 }, { "name": "Voco GmbH", "count": 5, "spellings": 1 } ], "newEntrants": [ { "name": "Hangzhou SHINING3D Dental Technology Co., Ltd.", "since": "2026-04-17", "kNumber": "K261261" }, { "name": "Liaoning Upcera Co., Ltd.", "since": "2026-03-02", "kNumber": "K253380" } ], "baseline": { "months": [ { "month": "2025-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "EBG (Crown And Bridge, Temporary, Resin) has two findings, most consequential first. 2 first-time filers in the last 12 months, Hangzhou SHINING3D Dental Technology Co., Ltd. and Liaoning Upcera Co., Ltd (K261261, K253380). The code is crowded, scoring 74 of 100 — 130 companies hold a clearance here and 2 arrived in the last 12 months (EBG:crowding).", "severity": 42, "factors": [ { "kind": "new_entrant", "detail": "2 first-time filers in the last 12 months, Hangzhou SHINING3D Dental Technology Co., Ltd. and Liaoning Upcera Co., Ltd.", "recordIds": [ "K261261", "K253380" ], "severity": 42 }, { "kind": "crowding", "detail": "the code is crowded, scoring 74 of 100 — 130 companies hold a clearance here and 2 arrived in the last 12 months", "recordIds": [ "EBG: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%3AEBG" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEBG" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEBG" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEBG" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEBG" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEBG" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEBG" } ], "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": "2026-08-11T13:51:45.689Z" }