{
  "code": "ELW",
  "deviceName": "Material, Impression",
  "deviceClass": "II",
  "regulationNumber": "872.3660",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 402,
    "last12Months": 2
  },
  "adverseEvents": {
    "total": 31,
    "last12Months": 11
  },
  "reviewDays": {
    "median": 70,
    "sampleSize": 402
  },
  "recalls": {
    "total": 14,
    "recent": [
      {
        "resNumber": "Z-1100-2022",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Clinician's Choice Dental Products Inc.",
        "firmAsPublished": "Clinician's Choice Dental Products Inc.",
        "reason": "Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK",
        "initiated": "2022-03-18"
      },
      {
        "resNumber": "Z-0717-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ivoclar Vivadent, Inc.",
        "firmAsPublished": "Ivoclar Vivadent, Inc.",
        "reason": "The firm received complaints claiming the dental material failed to set up.  As the dental material ages, the set time may increase.",
        "initiated": "2016-11-09"
      },
      {
        "resNumber": "Z-0718-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ivoclar Vivadent, Inc.",
        "firmAsPublished": "Ivoclar Vivadent, Inc.",
        "reason": "The firm received complaints claiming the dental material failed to set up.  As the dental material ages, the set time may increase.",
        "initiated": "2016-11-09"
      },
      {
        "resNumber": "Z-0719-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Ivoclar Vivadent, Inc.",
        "firmAsPublished": "Ivoclar Vivadent, Inc.",
        "reason": "The firm received complaints claiming the dental material failed to set up.  As the dental material ages, the set time may increase.",
        "initiated": "2016-11-09"
      },
      {
        "resNumber": "Z-0535-2014",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "3M Company - Health Care Business",
        "firmAsPublished": "3M Company - Health Care Business",
        "reason": "Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.",
        "initiated": "2013-11-21"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K254112",
      "deviceName": "Dia-X Sil Bite",
      "applicant": "DiaDent Group International",
      "company": "DiaDent Group International",
      "decisionDate": "2026-03-19",
      "dateReceived": "2025-12-19"
    },
    {
      "kNumber": "K253501",
      "deviceName": "Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set  - Multi Pack  (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);",
      "applicant": "Vigodent Indústria E Comercio Ltda",
      "company": "VIGODENT INDUSTRIA E COMERCIO LTDA",
      "decisionDate": "2025-10-31",
      "dateReceived": "2025-10-30"
    },
    {
      "kNumber": "K250969",
      "deviceName": "JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST",
      "applicant": "Dent4you AG",
      "company": "Dent4you AG",
      "decisionDate": "2025-06-27",
      "dateReceived": "2025-03-31"
    },
    {
      "kNumber": "K241924",
      "deviceName": "Elastic Impression Material",
      "applicant": "Beijing Okvd Biological Technology , Ltd.",
      "company": "Beijing Okvd Biological Technology , Ltd.",
      "decisionDate": "2024-12-27",
      "dateReceived": "2024-07-01"
    },
    {
      "kNumber": "K242360",
      "deviceName": "Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator",
      "applicant": "Dent4you AG",
      "company": "Dent4you AG",
      "decisionDate": "2024-11-15",
      "dateReceived": "2024-08-09"
    },
    {
      "kNumber": "K233954",
      "deviceName": "Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu",
      "applicant": "B&E Korea Co., Ltd.",
      "company": "B&E Korea Co., Ltd.",
      "decisionDate": "2024-02-13",
      "dateReceived": "2023-12-15"
    },
    {
      "kNumber": "K223892",
      "deviceName": "DentMix VPS Impression Material",
      "applicant": "Innovative Product Brands, Inc.",
      "company": "Innovative Product Brands, Inc.",
      "decisionDate": "2023-04-27",
      "dateReceived": "2022-12-28"
    },
    {
      "kNumber": "K213175",
      "deviceName": "No Stress Impress",
      "applicant": "No Stress Impress, LLC",
      "company": "No Stress Impress, LLC",
      "decisionDate": "2023-01-19",
      "dateReceived": "2021-09-28"
    },
    {
      "kNumber": "K214086",
      "deviceName": "Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty",
      "applicant": "Genoss Co., Ltd.",
      "company": "Genoss Co., Ltd.",
      "decisionDate": "2022-12-15",
      "dateReceived": "2021-12-27"
    },
    {
      "kNumber": "K222741",
      "deviceName": "DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)",
      "applicant": "Hdi, Inc.",
      "company": "Hdi, Inc.",
      "decisionDate": "2022-11-07",
      "dateReceived": "2022-09-09"
    }
  ],
  "topApplicants": [
    {
      "name": "Zhermack S.P.A.",
      "count": 19
    },
    {
      "name": "Dentsply Intl.",
      "count": 18
    },
    {
      "name": "Cavex Holland BV",
      "count": 16
    },
    {
      "name": "GC America, Inc.",
      "count": 15
    },
    {
      "name": "Heraeus Kulzer, Inc.",
      "count": 15
    }
  ],
  "topCompanies": [
    {
      "name": "Heraeus Kulzer, LLC.",
      "count": 21,
      "spellings": 3
    },
    {
      "name": "Zhermack S.P.A.",
      "count": 19,
      "spellings": 1
    },
    {
      "name": "Dentsply Intl., Inc.",
      "count": 18,
      "spellings": 1
    },
    {
      "name": "Cavex Holland BV",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "GC America, Inc.",
      "count": 15,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "DiaDent Group International",
      "since": "2026-03-19",
      "kNumber": "K254112"
    },
    {
      "name": "VIGODENT INDUSTRIA E COMERCIO LTDA",
      "since": "2025-10-31",
      "kNumber": "K253501"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-03-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-06-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-04-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-09-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-01-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-06-01",
        "observed": 12,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2025-09-01",
        "observed": 11,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "ELW (Material, Impression) has two findings, most consequential first. 2 first-time filers in the last 12 months, DiaDent Group International and VIGODENT INDUSTRIA E COMERCIO LTDA (K254112, K253501). The code is crowded, scoring 76 of 100 — 153 companies hold a clearance here and 2 arrived in the last 12 months (ELW:crowding).",
    "severity": 42,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "2 first-time filers in the last 12 months, DiaDent Group International and VIGODENT INDUSTRIA E COMERCIO LTDA",
        "recordIds": [
          "K254112",
          "K253501"
        ],
        "severity": 42
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 76 of 100 — 153 companies hold a clearance here and 2 arrived in the last 12 months",
        "recordIds": [
          "ELW: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%3AELW"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AELW"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AELW"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AELW"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AELW"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AELW"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AELW"
    }
  ],
  "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": "2026-08-11T13:51:45.694Z"
}