{ "code": "DZE", "deviceName": "Implant, Endosseous, Root-Form", "deviceClass": "II", "regulationNumber": "872.3640", "panel": "Dental", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 1547, "last12Months": 27 }, "adverseEvents": { "total": 1471766, "last12Months": 297306 }, "reviewDays": { "median": 156, "sampleSize": 1547 }, "recalls": { "total": 210, "recent": [ { "resNumber": "Z-0017-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "S.I.N. Implant System Ltda", "firmAsPublished": "S.I.N. Implant System Ltda", "reason": "Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.", "initiated": "2025-07-30" }, { "resNumber": "Z-1862-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Straumann USA, LLC", "firmAsPublished": "Straumann USA LLC", "reason": "It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.", "initiated": "2025-05-01" }, { "resNumber": "Z-1863-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Straumann USA, LLC", "firmAsPublished": "Straumann USA LLC", "reason": "It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.", "initiated": "2025-05-01" }, { "resNumber": "Z-1101-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "Nobel Biocare", "firmAsPublished": "Nobel Biocare", "reason": "Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.", "initiated": "2025-01-10" }, { "resNumber": "Z-0920-2025", "status": "Open, Classified", "recallClass": "Class II", "firm": "SIN SISTEMA DE IMPLANTE NACIONAL S.A", "firmAsPublished": "SIN SISTEMA DE IMPLANTE NACIONAL S.A", "reason": "Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.", "initiated": "2024-09-01" } ] }, "recentClearances": [ { "kNumber": "K251188", "deviceName": "UNIQA® Dental Implants System", "applicant": "Uniqa Dental, Ltd.", "company": "Uniqa Dental, Ltd.", "decisionDate": "2026-06-25", "dateReceived": "2025-04-17" }, { "kNumber": "K251232", "deviceName": "MegaGen Zygoma Dental Implant System", "applicant": "Megagen Implant Co., Ltd.", "company": "Megagen Implant Co., Ltd.", "decisionDate": "2026-06-18", "dateReceived": "2025-04-22" }, { "kNumber": "K250806", "deviceName": "Dental Implant System", "applicant": "A.B. Dental Devices , Ltd.", "company": "A.B. Dental Devices , Ltd.", "decisionDate": "2026-06-18", "dateReceived": "2025-03-17" }, { "kNumber": "K260006", "deviceName": "INOSS System", "applicant": "Inosys, Inc.", "company": "Inosys, Inc.", "decisionDate": "2026-06-17", "dateReceived": "2026-01-02" }, { "kNumber": "K252731", "deviceName": "Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant", "applicant": "Promimic AB", "company": "Promimic AB", "decisionDate": "2026-05-12", "dateReceived": "2025-08-28" }, { "kNumber": "K252031", "deviceName": "Adin Long Dental Implant System", "applicant": "Adin Dental Implant Systems , Ltd.", "company": "Adin Dental Implant Systems , Ltd.", "decisionDate": "2026-03-23", "dateReceived": "2025-06-30" }, { "kNumber": "K253334", "deviceName": "ZENEX Implant System_Short (R-System)", "applicant": "Izenimplant Co., Ltd.", "company": "Izenimplant Co., Ltd.", "decisionDate": "2026-03-16", "dateReceived": "2025-09-30" }, { "kNumber": "K252168", "deviceName": "Straumann® BLC Implants - Indication Widening", "applicant": "Institut Straumann AG", "company": "Institut Straumann AG", "decisionDate": "2026-03-10", "dateReceived": "2025-07-10" }, { "kNumber": "K253493", "deviceName": "Dentis SQ-SL AXEL Fixture", "applicant": "Dentis Co., Ltd.", "company": "Dentis Co., Ltd.", "decisionDate": "2026-03-04", "dateReceived": "2025-10-27" }, { "kNumber": "K252197", "deviceName": "Nobel Biocare S Series Implants", "applicant": "Nobel Biocare AB", "company": "Nobel Biocare", "decisionDate": "2026-02-18", "dateReceived": "2025-07-14" } ], "topApplicants": [ { "name": "Nobelpharma USA, Inc.", "count": 51 }, { "name": "Steri-Oss, Inc.", "count": 40 }, { "name": "Implant Innovations, Inc.", "count": 37 }, { "name": "Minimatic Implant Technology", "count": 34 }, { "name": "Institut Straumann AG", "count": 30 } ], "topCompanies": [ { "name": "Nobelpharma USA, Inc.", "count": 51, "spellings": 1 }, { "name": "Steri-Oss, Inc.", "count": 40, "spellings": 1 }, { "name": "Implant Innovations, Inc.", "count": 37, "spellings": 1 }, { "name": "Minimatic Implant Technology", "count": 34, "spellings": 1 }, { "name": "Institut Straumann AG", "count": 31, "spellings": 2 } ], "newEntrants": [ { "name": "Inosys, Inc.", "since": "2026-06-17", "kNumber": "K260006" }, { "name": "Chengdu Besmile Medical Technology Co., Ltd.", "since": "2026-02-02", "kNumber": "K252286" }, { "name": "DIMPLO, Ltd.", "since": "2025-12-22", "kNumber": "K251605" }, { "name": "Paragon Implant Mfg., LLC", "since": "2025-10-30", "kNumber": "K251938" }, { "name": "S.I.N. Implant System Ltda", "since": "2025-08-13", "kNumber": "K251046" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 38591, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 38173, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 45964, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 41715, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-05-01", "observed": 46809, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-06-01", "observed": 52126, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 43529, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 42447, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 38904, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-01-01", "observed": 46687, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 47610, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 39594, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-04-01", "observed": 32872, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 33425, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-06-01", "observed": 31328, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-07-01", "observed": 35231, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-08-01", "observed": 40084, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-09-01", "observed": 44049, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 45429, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-11-01", "observed": 49595, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 52804, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 40828, "expectedLow": 29800.893697622356, "expectedHigh": 54555.97654515485, "isSufficient": true }, { "month": "2025-02-01", "observed": 32824, "expectedLow": 26078.22543366512, "expectedHigh": 46732.47637739587, "isSufficient": true }, { "month": "2025-03-01", "observed": 35185, "expectedLow": 29027.45822999619, "expectedHigh": 49857.19527960859, "isSufficient": true }, { "month": "2025-04-01", "observed": 16495, "expectedLow": 28626.56736675713, "expectedHigh": 50080.45902403915, "isSufficient": true }, { "month": "2025-05-01", "observed": 11225, "expectedLow": 15115.286872973435, "expectedHigh": 45780.477385422906, "isSufficient": true }, { "month": "2025-06-01", "observed": 21325, "expectedLow": 4624.559751290005, "expectedHigh": 46594.14444652376, "isSufficient": true }, { "month": "2025-07-01", "observed": 93325, "expectedLow": 3274.3960113097387, "expectedHigh": 73128.85524518773, "isSufficient": true }, { "month": "2025-08-01", "observed": 44110, "expectedLow": 9607.59182669765, "expectedHigh": 73280.68282406496, "isSufficient": true }, { "month": "2025-09-01", "observed": 38268, "expectedLow": 11025.086184888243, "expectedHigh": 78063.44684125026, "isSufficient": true }, { "month": "2025-10-01", "observed": 37732, "expectedLow": 9074.240168843926, "expectedHigh": 75632.3355100096, "isSufficient": true }, { "month": "2025-11-01", "observed": 38437, "expectedLow": 7014.269495337858, "expectedHigh": 67029.65815338776, "isSufficient": true }, { "month": "2025-12-01", "observed": 42604, "expectedLow": 9339.193353204762, "expectedHigh": 73698.25508704642, "isSufficient": true }, { "month": "2026-01-01", "observed": 38530, "expectedLow": 12864.037019742027, "expectedHigh": 83449.38225035842, "isSufficient": true }, { "month": "2026-02-01", "observed": 41836, "expectedLow": 8790.326139835628, "expectedHigh": 67694.17872112576, "isSufficient": true }, { "month": "2026-03-01", "observed": 37953, "expectedLow": 11008.279029045903, "expectedHigh": 75148.85046867252, "isSufficient": true } ], "sufficientMonths": 15, "method": "ewma_alpha_0.3_sd_2 corpus_adjusted" }, "signal": { "summary": "DZE (Implant, Endosseous, Root-Form) has three findings, most consequential first. 5 first-time filers in the last 12 months, including Inosys, Inc. and Chengdu Besmile Medical Technology Co., Ltd (K260006, K252286, K251605, K251938, K251046). Clearances are running 28% slower — a median 200 days over the last 12 months against 156 days all-time (elapsed calendar days, not FDA review days) (DZE:review_time:12m). The code is crowded, scoring 98 of 100 — 425 companies hold a clearance here and 27 arrived in the last 12 months (DZE:crowding).", "severity": 45, "factors": [ { "kind": "new_entrant", "detail": "5 first-time filers in the last 12 months, including Inosys, Inc. and Chengdu Besmile Medical Technology Co., Ltd.", "recordIds": [ "K260006", "K252286", "K251605", "K251938", "K251046" ], "severity": 45 }, { "kind": "review_time_shift", "detail": "clearances are running 28% slower — a median 200 days over the last 12 months against 156 days all-time (elapsed calendar days, not FDA review days)", "recordIds": [ "DZE:review_time:12m" ], "severity": 30 }, { "kind": "crowding", "detail": "the code is crowded, scoring 98 of 100 — 425 companies hold a clearance here and 27 arrived in the last 12 months", "recordIds": [ "DZE: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%3ADZE" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADZE" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADZE" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADZE" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADZE" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADZE" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADZE" } ], "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" }