{
  "format": "devicerts.device.v1",
  "cite_as": "Argen Clear Aligner, Argen Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/argen-clear-aligner-nxc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/argen-clear-aligner-nxc",
    "json_url": "https://devicerts.com/devices/argen-clear-aligner-nxc.json",
    "markdown_url": "https://devicerts.com/devices/argen-clear-aligner-nxc.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/argen-clear-aligner-nxc",
    "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": "Argen Clear Aligner",
    "registry_name": "Argen Clear Aligner",
    "url": "https://devicerts.com/devices/argen-clear-aligner-nxc",
    "manufacturer": {
      "name": "Argen Corporation",
      "url": "https://devicerts.com/manufacturers/the-argen-corporation",
      "country": "United States",
      "country_basis": null,
      "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": "K183229",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "NXC"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Argen Clear Aligner is a removable dental appliance classified as a sequential aligner, designed to gradually reposition teeth for orthodontic correction. It is intended for use in treating anterior and premolar malocclusion, providing a clear, esthetic alternative to traditional braces.\n\nThese aligners are supplied as single-use, non-sterile devices and are manufactured from thermoformed plastic material. They are intended for use in dental offices and laboratories, with sizes and configurations tailored to individual patient needs. The device holds an FDA 510(k) clearance under the classification of Class II (NXC), with registration numbers including 2082148 and others listed. Storage and handling follow standard dental practice guidelines.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "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": "K183229",
      "number_label": null,
      "device_udi_di": null,
      "date": "2019-06-07",
      "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": "K183229",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "NXC",
              "registries": [
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 872.5470",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Dental",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}