{
  "format": "devicerts.device.v1",
  "cite_as": "MTA2.1 Material, Avalon Biomed Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/mta2-1-material-kif (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/mta2-1-material-kif",
    "json_url": "https://devicerts.com/devices/mta2-1-material-kif.json",
    "markdown_url": "https://devicerts.com/devices/mta2-1-material-kif.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "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/devices/mta2-1-material-kif",
    "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."
  },
  "device": {
    "name": "MTA2.1 Material",
    "registry_name": "MTA2.1 MATERIAL",
    "url": "https://devicerts.com/devices/mta2-1-material-kif",
    "manufacturer": {
      "name": "Avalon Biomed Inc.",
      "url": "https://devicerts.com/manufacturers/avalon-biomed-inc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K140955",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "KIF"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The MTA2.1 Material is a resin-based root canal filling material designed for use in dental procedures involving contact with vital pulp tissue and periradicular tissue. It is intended for applications such as pulp capping, cavity lining, base material, pulpotomy, and root-end filling, as well as sealing and obturation of root canals.\n\nSupplied as a non-sterile, single-use material for dental clinical settings, the MTA2.1 Material is regulated under FDA 510(k) clearance (K140955) as a Class II device with product code KIF. It is not indicated for MRI safety assessment, and no sterility, storage, or reuse specifications are provided in the data.",
      "ai_generated": true,
      "generated_on": "2026-09-24",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K140955",
      "number_label": null,
      "device_udi_di": null,
      "date": "2014-06-11",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K140955",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "KIF",
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
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              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 872.3820",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Dental",
              "registries": [
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            }
          ]
        },
        {
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            {
              "value": "SESE",
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              ]
            }
          ]
        }
      ]
    }
  ]
}