{
  "format": "devicerts.device.v1",
  "cite_as": "Statis Dental Handpieces, Scican Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/statis-dental-handpieces-efb (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/statis-dental-handpieces-efb",
    "json_url": "https://devicerts.com/devices/statis-dental-handpieces-efb.json",
    "markdown_url": "https://devicerts.com/devices/statis-dental-handpieces-efb.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "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/statis-dental-handpieces-efb",
    "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": "Statis Dental Handpieces",
    "registry_name": "STATIS DENTAL HANDPIECES",
    "url": "https://devicerts.com/devices/statis-dental-handpieces-efb",
    "manufacturer": {
      "name": "Scican Ltd",
      "url": "https://devicerts.com/manufacturers/scican-ltd",
      "country": "Canada",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class I",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
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        "values": [
          {
            "value": "K071891",
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              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "EFB"
    ],
    "emdn": [],
    "gmdn": [],
    "description": null,
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K071891",
      "number_label": null,
      "device_udi_di": null,
      "date": "2007-09-13",
      "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": [
    {
      "number": "Z-1208-2023",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2023-01-20",
      "reason": "Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button",
      "applies": "this device",
      "via": "K071891"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K071891",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "EFB",
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              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
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        {
          "label": "Device class",
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            {
              "value": "Class I",
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            }
          ]
        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 872.4200",
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          ]
        },
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          ]
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          ]
        }
      ]
    }
  ]
}