{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Alpha-Dent. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/alpha-dent (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/alpha-dent",
    "json_url": "https://devicerts.com/manufacturers/alpha-dent.json",
    "markdown_url": "https://devicerts.com/manufacturers/alpha-dent.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/alpha-dent",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Alpha-Dent",
    "url": "https://devicerts.com/manufacturers/alpha-dent",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Alphadent Co., Ltd."
    ],
    "country": null,
    "country_basis": null,
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer",
      "Part of a group"
    ],
    "registrations": [],
    "identifiers": [],
    "summary": "Alpha-Dent is a medical device manufacturer, with 7 devices listed in FDA 510(k) (FDA Class II) as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 7,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA 510(k)",
        "devices": 7
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 7
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": {
      "name": "Alphadent NV",
      "url": "https://devicerts.com/manufacturers/alphadent-nv"
    },
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 7,
    "total": 7,
    "all_devices_url": "https://devicerts.com/manufacturers/alpha-dent",
    "items": [
      {
        "name": "Centrix's Encore Solo Light Activated Resin Core",
        "url": "https://devicerts.com/devices/centrixs-encore-solo-light-activated-resin-core-ebf",
        "model_reference": "K932828",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1994-02-03",
        "open_recall": false
      },
      {
        "name": "Centrix's Encore Natural Composite Resin Core Past",
        "url": "https://devicerts.com/devices/centrixs-encore-natural-composite-resin-core-past-ebf",
        "model_reference": "K932829",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1994-01-28",
        "open_recall": false
      },
      {
        "name": "Ceramax",
        "url": "https://devicerts.com/devices/ceramax-eih",
        "model_reference": "K062504",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2006-09-05",
        "open_recall": false
      },
      {
        "name": "Composite Restorative Material/Radiopaque",
        "url": "https://devicerts.com/devices/composite-restorative-material-radiopaque-ebf",
        "model_reference": "K904812",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1991-02-26",
        "open_recall": false
      },
      {
        "name": "Visible Light Cure Composite Dental Restor. Mat.",
        "url": "https://devicerts.com/devices/visible-light-cure-composite-dental-restor-mat-ebf",
        "model_reference": "K904813",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1991-05-31",
        "open_recall": false
      },
      {
        "name": "Alpha-Dent Core Buildup Paste",
        "url": "https://devicerts.com/devices/alpha-dent-core-buildup-paste-ebf",
        "model_reference": "K932827",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1993-09-23",
        "open_recall": false
      },
      {
        "name": "Centrix's Encore Composite Resin Core Paste W\\fluo",
        "url": "https://devicerts.com/devices/centrixs-encore-composite-resin-core-paste-w-fluo-ebf",
        "model_reference": "K932826",
        "device_class": "Class II",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "1994-01-28",
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": []
}