{
  "code": "NHA",
  "deviceName": "Abutment, Implant, Dental, Endosseous",
  "deviceClass": "II",
  "regulationNumber": "872.3630",
  "panel": "Dental",
  "definition": "To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 712,
    "last12Months": 37
  },
  "adverseEvents": {
    "total": 2509,
    "last12Months": 863
  },
  "reviewDays": {
    "median": 141,
    "sampleSize": 712
  },
  "recalls": {
    "total": 224,
    "recent": [
      {
        "resNumber": "Z-1994-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Straumann USA, LLC",
        "firmAsPublished": "Straumann USA LLC",
        "reason": "Includes an incorrect screw seat interface.",
        "initiated": "2026-03-27"
      },
      {
        "resNumber": "Z-1995-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Straumann USA, LLC",
        "firmAsPublished": "Straumann USA LLC",
        "reason": "Includes an incorrect screw seat interface.",
        "initiated": "2026-03-27"
      },
      {
        "resNumber": "Z-1632-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Straumann USA, LLC",
        "firmAsPublished": "Straumann USA LLC",
        "reason": "A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.",
        "initiated": "2026-03-17"
      },
      {
        "resNumber": "Z-1633-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Straumann USA, LLC",
        "firmAsPublished": "Straumann USA LLC",
        "reason": "A material mix-up had occurred during the manufacturing of Straumann Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.",
        "initiated": "2026-03-17"
      },
      {
        "resNumber": "Z-0417-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Prismatik Dentalcraft, Inc.",
        "firmAsPublished": "Prismatik Dentalcraft, Inc.",
        "reason": "Incorrect titanium screw, packaged with dental implant.",
        "initiated": "2025-09-30"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261147",
      "deviceName": "Neodent Implant System - NeoConvert Fit",
      "applicant": "JJGC Indústria e Comércio de Materiais Dentários S.A.",
      "company": "Jjgc Industria E Comercio DE Materiais Dentarios S.A.",
      "decisionDate": "2026-07-01",
      "dateReceived": "2026-04-07"
    },
    {
      "kNumber": "K261122",
      "deviceName": "MIST IC",
      "applicant": "Imagine Milling Technologies, LLC",
      "company": "Imagine Milling Technologies, LLC",
      "decisionDate": "2026-06-27",
      "dateReceived": "2026-04-03"
    },
    {
      "kNumber": "K260061",
      "deviceName": "BioHorizons CEREC Compatible Ti-Bases",
      "applicant": "BioHorizons Implant Systems, Inc.",
      "company": "BioHorizons Implant Systems Inc",
      "decisionDate": "2026-06-26",
      "dateReceived": "2026-01-08"
    },
    {
      "kNumber": "K253922",
      "deviceName": "Neodent Scannable Healing Abutment",
      "applicant": "JJGC Indústria e Comércio de Materiais Dentários S.A.",
      "company": "Jjgc Industria E Comercio DE Materiais Dentarios S.A.",
      "decisionDate": "2026-06-15",
      "dateReceived": "2025-12-08"
    },
    {
      "kNumber": "K254145",
      "deviceName": "Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)",
      "applicant": "Smart Denture Conversions, LLC",
      "company": "Smart Denture Conversions, LLC",
      "decisionDate": "2026-06-11",
      "dateReceived": "2025-12-22"
    },
    {
      "kNumber": "K260564",
      "deviceName": "DESS Dental Smart Solutions",
      "applicant": "Terrats Medical SL",
      "company": "Terrats Medical SL",
      "decisionDate": "2026-06-09",
      "dateReceived": "2026-02-19"
    },
    {
      "kNumber": "K252904",
      "deviceName": "SIC Abutments including CAD/CAM Solutions",
      "applicant": "Sic Invent AG",
      "company": "Sic Invent AG",
      "decisionDate": "2026-06-03",
      "dateReceived": "2025-09-11"
    },
    {
      "kNumber": "K253774",
      "deviceName": "Elos Accurate® Denture Fixation System",
      "applicant": "Elos Medtech Pinol A/S",
      "company": "Elos Medtech Pinol A/S",
      "decisionDate": "2026-05-20",
      "dateReceived": "2025-11-26"
    },
    {
      "kNumber": "K253372",
      "deviceName": "ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments",
      "applicant": "Hiossen, Inc.",
      "company": "Hiossen, Inc.",
      "decisionDate": "2026-05-14",
      "dateReceived": "2025-09-30"
    },
    {
      "kNumber": "K260460",
      "deviceName": "Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue",
      "applicant": "Institut Straumann AG",
      "company": "Institut Straumann AG",
      "decisionDate": "2026-05-07",
      "dateReceived": "2026-02-11"
    }
  ],
  "topApplicants": [
    {
      "name": "Institut Straumann AG",
      "count": 46
    },
    {
      "name": "Nobel Biocare AB",
      "count": 41
    },
    {
      "name": "Terrats Medical SL",
      "count": 21
    },
    {
      "name": "Zimmer Dental, Inc.",
      "count": 21
    },
    {
      "name": "Dentsply Sirona",
      "count": 20
    }
  ],
  "topCompanies": [
    {
      "name": "Institut Straumann AG",
      "count": 47,
      "spellings": 2
    },
    {
      "name": "Nobel Biocare",
      "count": 42,
      "spellings": 2
    },
    {
      "name": "Straumann USA, LLC",
      "count": 31,
      "spellings": 2
    },
    {
      "name": "Dentsply Sirona, Inc.",
      "count": 23,
      "spellings": 2
    },
    {
      "name": "Terrats Medical SL",
      "count": 21,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Sic Invent AG",
      "since": "2026-06-03",
      "kNumber": "K252904"
    },
    {
      "name": "CreoDent Hudson Valley",
      "since": "2026-02-10",
      "kNumber": "K251515"
    },
    {
      "name": "Orangecad Med GmbH",
      "since": "2025-12-23",
      "kNumber": "K253312"
    },
    {
      "name": "Adin Dental Implant Systems , Ltd.",
      "since": "2025-10-17",
      "kNumber": "K250178"
    },
    {
      "name": "S.I.N. Implant System Ltda",
      "since": "2025-10-17",
      "kNumber": "K252266"
    },
    {
      "name": "Chengdu Besmile Medical Technology Co., Ltd.",
      "since": "2025-09-02",
      "kNumber": "K242768"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 68,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 26,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 57,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 28,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-05-01",
        "observed": 75,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 41,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 52,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 89,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 57,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-01-01",
        "observed": 85,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 38,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-03-01",
        "observed": 60,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 34,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 74,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 51,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-07-01",
        "observed": 54,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-08-01",
        "observed": 42,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 42,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 64,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-11-01",
        "observed": 55,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-12-01",
        "observed": 36,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 55,
        "expectedLow": 13.864413097610617,
        "expectedHigh": 74.98707552648862,
        "isSufficient": true
      },
      {
        "month": "2025-02-01",
        "observed": 34,
        "expectedLow": 20.600582245344455,
        "expectedHigh": 61.234671181726824,
        "isSufficient": true
      },
      {
        "month": "2025-03-01",
        "observed": 63,
        "expectedLow": 21.271888625354876,
        "expectedHigh": 66.28487014442658,
        "isSufficient": true
      },
      {
        "month": "2025-04-01",
        "observed": 93,
        "expectedLow": 26.708313039883286,
        "expectedHigh": 74.97670832342276,
        "isSufficient": true
      },
      {
        "month": "2025-05-01",
        "observed": 45,
        "expectedLow": 28.446553917821156,
        "expectedHigh": 91.55068971043555,
        "isSufficient": true
      },
      {
        "month": "2025-06-01",
        "observed": 67,
        "expectedLow": 26.138966946152383,
        "expectedHigh": 88.50776704174687,
        "isSufficient": true
      },
      {
        "month": "2025-07-01",
        "observed": 125,
        "expectedLow": 43.19238235681358,
        "expectedHigh": 145.93326092317605,
        "isSufficient": true
      },
      {
        "month": "2025-08-01",
        "observed": 46,
        "expectedLow": 35.130176425416586,
        "expectedHigh": 121.27936859799973,
        "isSufficient": true
      },
      {
        "month": "2025-09-01",
        "observed": 53,
        "expectedLow": 27.29545623356221,
        "expectedHigh": 117.02031464591708,
        "isSufficient": true
      },
      {
        "month": "2025-10-01",
        "observed": 123,
        "expectedLow": 22.423885549159614,
        "expectedHigh": 110.07481791991306,
        "isSufficient": true
      },
      {
        "month": "2025-11-01",
        "observed": 31,
        "expectedLow": 26.18813356733812,
        "expectedHigh": 123.77777506676543,
        "isSufficient": true
      },
      {
        "month": "2025-12-01",
        "observed": 95,
        "expectedLow": 9.958225640577213,
        "expectedHigh": 126.3543209071132,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 237,
        "expectedLow": 23.4399847359214,
        "expectedHigh": 153.307954229037,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 151,
        "expectedLow": 20.827901208707793,
        "expectedHigh": 203.59880700923108,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 139,
        "expectedLow": 31.574406311052446,
        "expectedHigh": 240.90021318614816,
        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "NHA (Abutment, Implant, Dental, Endosseous) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1994-2026, Z-1995-2026, Z-1632-2026, Z-1633-2026, Z-0417-2026). 6 first-time filers in the last 12 months, including Sic Invent AG and CreoDent Hudson Valley (K252904, K251515, K253312, K250178, K252266). The code is crowded, scoring 97 of 100 — 155 companies hold a clearance here and 37 arrived in the last 12 months (NHA:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-1994-2026",
          "Z-1995-2026",
          "Z-1632-2026",
          "Z-1633-2026",
          "Z-0417-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "6 first-time filers in the last 12 months, including Sic Invent AG and CreoDent Hudson Valley",
        "recordIds": [
          "K252904",
          "K251515",
          "K253312",
          "K250178",
          "K252266"
        ],
        "severity": 46
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 97 of 100 — 155 companies hold a clearance here and 37 arrived in the last 12 months",
        "recordIds": [
          "NHA: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%3ANHA"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANHA"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ANHA"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ANHA"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ANHA"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ANHA"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ANHA"
    }
  ],
  "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": "2026-08-11T13:51:45.748Z"
}