{
  "format": "devicerts.device.v1",
  "cite_as": "CL-DC20, CL-DC21, Good Doctors Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/cl-dc20-cl-dc21-ebz (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/cl-dc20-cl-dc21-ebz",
    "json_url": "https://devicerts.com/devices/cl-dc20-cl-dc21-ebz.json",
    "markdown_url": "https://devicerts.com/devices/cl-dc20-cl-dc21-ebz.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/cl-dc20-cl-dc21-ebz",
    "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": "CL-DC20, CL-DC21",
    "registry_name": "CL-DC20, CL-DC21",
    "url": "https://devicerts.com/devices/cl-dc20-cl-dc21-ebz",
    "manufacturer": {
      "name": "Good Doctors Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/fda-fei-3006621353",
      "country": "South Korea",
      "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": "K093751",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "EBZ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The device is a dental curing light, specifically the CL-DC20 and CL-DC21 models, designed for the polymerization of dental composites using visible light. It is classified as a Class II medical device under FDA regulation number 872.6070 and has received traditional 510(k) clearance as substantially equivalent to a predicate device.\n\nThe device is supplied as a reusable handpiece unit with dimensions of 232 x 40 x 26 mm and a weight of 107 g (including battery). It operates with selectable curing modes, light intensity, and time settings, and is intended for use in dental clinical settings. Storage and handling should follow the manufacturer's instructions as detailed in the user manual.",
      "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": "K093751",
      "number_label": null,
      "device_udi_di": null,
      "date": "2010-02-24",
      "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": "K093751",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "EBZ",
              "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 872.6070",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Dental",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}