{
  "code": "DYH",
  "deviceName": "Adhesive, Bracket And Tooth Conditioner, Resin",
  "deviceClass": "II",
  "regulationNumber": "872.3750",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 194,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 1,
    "last12Months": 1
  },
  "reviewDays": {
    "median": 65,
    "sampleSize": 194
  },
  "recalls": {
    "total": 1,
    "recent": [
      {
        "resNumber": "Z-0916-2008",
        "status": "Terminated",
        "recallClass": null,
        "firm": "Ormco Corporation",
        "firmAsPublished": "Ormco Corporation",
        "reason": "Mislabeled: Product mislabeled with incorrect expiration date.  Expiration date labeled as 2010/07 instead of 2009/07.",
        "initiated": "2007-10-31"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K261129",
      "deviceName": "OrthoFit",
      "applicant": "Spident Co., Ltd.",
      "company": "Spident Co., Ltd.",
      "decisionDate": "2026-07-02",
      "dateReceived": "2026-04-06"
    },
    {
      "kNumber": "K261840",
      "deviceName": "BracePaste Prime Plus",
      "applicant": "American Orthodontics",
      "company": "American Orthodontics Corp.",
      "decisionDate": "2026-06-03",
      "dateReceived": "2026-06-02"
    },
    {
      "kNumber": "K250015",
      "deviceName": "Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive",
      "applicant": "Ormco Corporation",
      "company": "Ormco Corporation",
      "decisionDate": "2025-01-03",
      "dateReceived": "2025-01-02"
    },
    {
      "kNumber": "K242537",
      "deviceName": "BracePaste Fluoride Sealant",
      "applicant": "American Orthodontics Corp.",
      "company": "American Orthodontics Corp.",
      "decisionDate": "2024-08-27",
      "dateReceived": "2024-08-26"
    },
    {
      "kNumber": "K234043",
      "deviceName": "3M™ Transbond™ Orthodontic Adhesive",
      "applicant": "3M Unitek Orthodontic Products",
      "company": "3M Unitek Orthodontic Products",
      "decisionDate": "2023-12-22",
      "dateReceived": "2023-12-21"
    },
    {
      "kNumber": "K231817",
      "deviceName": "AlignerFlow LC",
      "applicant": "Voco GmbH",
      "company": "Voco GmbH",
      "decisionDate": "2023-12-01",
      "dateReceived": "2023-06-21"
    },
    {
      "kNumber": "K214054",
      "deviceName": "TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520",
      "applicant": "Tp Orthodontics, Inc.",
      "company": "TP Orthodontics, Inc.",
      "decisionDate": "2022-10-14",
      "dateReceived": "2021-12-27"
    },
    {
      "kNumber": "K210115",
      "deviceName": "FiteBac CC OrthoSeal",
      "applicant": "Largent Health, LLC",
      "company": "Largent Health, LLC",
      "decisionDate": "2021-07-29",
      "dateReceived": "2021-01-19"
    },
    {
      "kNumber": "K202276",
      "deviceName": "BracePaste Band and Build LC",
      "applicant": "American Orthodontics",
      "company": "American Orthodontics Corp.",
      "decisionDate": "2020-08-14",
      "dateReceived": "2020-08-11"
    },
    {
      "kNumber": "K192682",
      "deviceName": "Orthocem, Ortho Bite",
      "applicant": "Dentscare Ltda",
      "company": "Dentscare Ltda",
      "decisionDate": "2020-08-14",
      "dateReceived": "2019-09-26"
    }
  ],
  "topApplicants": [
    {
      "name": "Reliance Orthodontic Products, Inc.",
      "count": 23
    },
    {
      "name": "Sybron Dental Specialties, Inc.",
      "count": 12
    },
    {
      "name": "Ormco Corp.",
      "count": 9
    },
    {
      "name": "American Orthodontics",
      "count": 7
    },
    {
      "name": "Dentsply Intl.",
      "count": 7
    }
  ],
  "topCompanies": [
    {
      "name": "Reliance Orthodontic Products, Inc.",
      "count": 23,
      "spellings": 1
    },
    {
      "name": "Sybron Dental Specialties",
      "count": 12,
      "spellings": 1
    },
    {
      "name": "Ormco Corporation",
      "count": 10,
      "spellings": 2
    },
    {
      "name": "Pulpdent Corporation",
      "count": 9,
      "spellings": 2
    },
    {
      "name": "American Orthodontics Corp.",
      "count": 8,
      "spellings": 2
    }
  ],
  "newEntrants": [
    {
      "name": "Spident Co., Ltd.",
      "since": "2026-07-02",
      "kNumber": "K261129"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2025-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "DYH (Adhesive, Bracket And Tooth Conditioner, Resin) has two findings, most consequential first. 1 first-time filer in the last 12 months, Spident Co., Ltd (K261129). The code is crowded, scoring 62 of 100 — 60 companies hold a clearance here and 2 arrived in the last 12 months (DYH:crowding).",
    "severity": 41,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "1 first-time filer in the last 12 months, Spident Co., Ltd.",
        "recordIds": [
          "K261129"
        ],
        "severity": 41
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 62 of 100 — 60 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "DYH: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%3ADYH"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADYH"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3ADYH"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3ADYH"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3ADYH"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3ADYH"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3ADYH"
    }
  ],
  "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": "2026-08-11T13:51:45.688Z"
}