{
  "format": "devicerts.device.v1",
  "cite_as": "DentiqGuide, 3D Industrial Imaging Co., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/dentiqguide-llz (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/dentiqguide-llz",
    "json_url": "https://devicerts.com/devices/dentiqguide-llz.json",
    "markdown_url": "https://devicerts.com/devices/dentiqguide-llz.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/dentiqguide-llz",
    "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": "DentiqGuide",
    "registry_name": "DentiqGuide",
    "url": "https://devicerts.com/devices/dentiqguide-llz",
    "manufacturer": {
      "name": "3D Industrial Imaging Co., Ltd.",
      "url": "https://devicerts.com/manufacturers/3d-industrial-imaging-co-ltd",
      "country": "South Korea",
      "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": "K180629",
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          }
        ]
      }
    ],
    "product_codes": [
      "LLZ"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "DentiqGuide is a planning software for digital dentistry, designed for prosthetic-driven planning, surgical guide fabrication, and comprehensive treatment workflows. It is a cloud-based system provided by 3D Industrial Imaging Co., Ltd.\n\nThe device is supplied as software and is used in dental treatment planning and surgical guide design. It received FDA 510(k) clearance (K180629) on July 19, 2018, and is classified under product code LLZ with advisory committee review in Radiology (RA).",
      "ai_generated": true,
      "generated_on": "2026-09-24",
      "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": "K180629",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-07-19",
      "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",
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            {
              "value": "K180629",
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            }
          ]
        },
        {
          "label": "FDA product code",
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              "value": "LLZ",
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          ]
        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 892.2050",
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}