{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Orametrix, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/orametrix-inc (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/orametrix-inc",
    "json_url": "https://devicerts.com/manufacturers/orametrix-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/orametrix-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-15",
    "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/manufacturers/orametrix-inc",
    "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."
  },
  "manufacturer": {
    "name": "Orametrix, Inc.",
    "url": "https://devicerts.com/manufacturers/orametrix-inc",
    "registered_as": "OraMetrix",
    "abbreviated_name": "OraMetrix",
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000018045"
      },
      {
        "label": "DUNS",
        "value": "053101262"
      }
    ],
    "summary": "Orametrix, Inc. is a medical device manufacturer based in the United States, with 30 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class I and II) as of 15 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 30,
    "devices_note": null,
    "certificates": 1,
    "fda_recalls_matched_by_name": 0,
    "fda_recalls_ongoing": 0,
    "fda_recalls_ongoing_recent": 0,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 1,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 29
      },
      {
        "registry": "EUDAMED",
        "devices": 3
      },
      {
        "registry": "FDA 510(k)",
        "devices": 1
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class I",
        "devices": 21
      },
      {
        "class": "FDA Class II",
        "devices": 9
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 30,
    "total": 30,
    "all_devices_url": "https://devicerts.com/manufacturers/orametrix-inc",
    "items": [
      {
        "name": "SureSmile® 2000",
        "url": "https://devicerts.com/devices/suresmile-r-2000-assy500020",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000110",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000110",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Motto ASSY-500017",
        "url": "https://devicerts.com/devices/motto-assy-500017",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile Advanced Software 7.6",
        "url": "https://devicerts.com/devices/suresmile-advanced-software-digi-500159",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000580",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000580",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000471",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000471",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® DIGI-500128",
        "url": "https://devicerts.com/devices/suresmile-r-digi-500128",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile Ortho Software 7.6",
        "url": "https://devicerts.com/devices/suresmile-ortho-software-digi-500153",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Motto ASSY-500019",
        "url": "https://devicerts.com/devices/motto-assy-500019",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000472",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000472",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Motto ASSY-500118",
        "url": "https://devicerts.com/devices/motto-assy-500018",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000116",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000116",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile attachment template 3000",
        "url": "https://devicerts.com/devices/suresmile-attachment-template-assy-500010",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000469",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000469",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000112",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000112",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "sureclear template 2000",
        "url": "https://devicerts.com/devices/sureclear-template-2000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000117",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000117",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile Aligner Software 7.6",
        "url": "https://devicerts.com/devices/suresmile-aligner-software-7-6",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® 1000",
        "url": "https://devicerts.com/devices/suresmile-r-assy-500011",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000108",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000108",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000470",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000470",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "sureclear aligner 1000",
        "url": "https://devicerts.com/devices/sureclear-aligner-1000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® 1000",
        "url": "https://devicerts.com/devices/suresmile-r-assy-500016",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000115",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000115",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000473",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000473",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000109",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000109",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® 1000",
        "url": "https://devicerts.com/devices/suresmile-r-assy-500015",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile® ASSY-000149",
        "url": "https://devicerts.com/devices/suresmile-r-assy-000149",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "SureSmile attachment template 2000",
        "url": "https://devicerts.com/devices/suresmile-attachment-template-2000",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Withdrawn",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Suresmile System",
        "url": "https://devicerts.com/devices/suresmile-system-eia",
        "model_reference": "K002620",
        "device_class": "Class I",
        "registries": [
          "510(k)"
        ],
        "status": "Active",
        "decision_date": "2000-11-16",
        "open_recall": false
      }
    ]
  },
  "certificates": [
    {
      "number": "G10 061588 0012",
      "type": "Quality management system",
      "legislation": "MDR",
      "notified_body": "TÜV SÜD Product Service GmbH",
      "issued": "2025-02-27",
      "expires": "2030-05-13",
      "status": "reissued",
      "no_longer_listed": false
    }
  ],
  "recalls": []
}