{
  "format": "devicerts.device.v1",
  "cite_as": "MTA2 Root and Pulp Materials, Avalon Biomed Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/mta2-root-and-pulp-materials-kif (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/mta2-root-and-pulp-materials-kif",
    "json_url": "https://devicerts.com/devices/mta2-root-and-pulp-materials-kif.json",
    "markdown_url": "https://devicerts.com/devices/mta2-root-and-pulp-materials-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-root-and-pulp-materials-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 Root and Pulp Materials",
    "registry_name": "MTA2 ROOT AND PULP MATERIALS",
    "url": "https://devicerts.com/devices/mta2-root-and-pulp-materials-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": "K122892",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "KIF"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The MTA2 Root and Pulp Materials is a Root Canal Filling Resin (FDA classification 872.3820) designed for dental procedures involving pulp and periradicular tissues. It serves as a biocompatible material for root canal obturation and sealing, promoting tissue compatibility and structural integrity in endodontic treatments. Its formulation supports sealing properties essential for preventing microbial leakage and maintaining long-term periradicular healing.\n\nSupplied as a single-use dental material, MTA2 is intended for clinical use in controlled environments such as dental offices or clinics. The product is not sterile at time of shipment but is intended to be prepared and applied under aseptic conditions. No specific MRI safety information is provided, and its use adheres to standard dental infection control protocols. Authorized under FDA 510(k) clearance (K122892) as a Class II device, it complies with dental regulatory standards for root canal filling materials.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "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": "K122892",
      "number_label": null,
      "device_udi_di": null,
      "date": "2012-12-11",
      "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": "K122892",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "KIF",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 872.3820",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Dental",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}