{
  "format": "devicerts.device.v1",
  "cite_as": "One-Fil Putty Injectable, MEDICLUS Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/one-fil-putty-injectable-kif (data as of 2026-11-15).",
  "source": {
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    "json_url": "https://devicerts.com/devices/one-fil-putty-injectable-kif.json",
    "markdown_url": "https://devicerts.com/devices/one-fil-putty-injectable-kif.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "registry_records_last_synced": "2026-11-12",
    "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/one-fil-putty-injectable-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": "One-Fil Putty Injectable",
    "registry_name": "One-Fil Putty Injectable",
    "url": "https://devicerts.com/devices/one-fil-putty-injectable-kif",
    "manufacturer": {
      "name": "MEDICLUS Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/mediclus-co-ltd",
      "country": "South Korea",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K251884",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "KIF"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The One-Fil Putty Injectable is a premixed bioceramic cement designed for permanent root canal filling. It is formulated with a tricalcium silicate composition that sets and hardens in the presence of moisture, providing a durable seal within the root canal system.\n\nThis device is supplied as a single-use, non-sterile material intended for dental use under aseptic conditions. It is classified as a Class II medical device under FDA regulations (product code KIF) and has received FDA 510(k) clearance. The material is packaged for direct application in endodontic procedures and is not intended for MRI use.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
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  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K251884",
      "number_label": null,
      "device_udi_di": null,
      "date": "2025-08-22",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDD",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
      "date_kind": null,
      "decision_code": null,
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      "status": "Active",
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      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
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        {
          "label": "510(k) Number",
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            {
              "value": "K251884",
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            }
          ]
        },
        {
          "label": "FDA product code",
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            {
              "value": "KIF",
              "registries": [
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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",
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Dental",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "FDA decision",
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            {
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}