{
  "format": "devicerts.device.v1",
  "cite_as": "rainbow Shine, GENOSS CO., Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/rainbow-shine-eih-k160079 (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/rainbow-shine-eih-k160079",
    "json_url": "https://devicerts.com/devices/rainbow-shine-eih-k160079.json",
    "markdown_url": "https://devicerts.com/devices/rainbow-shine-eih-k160079.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": "2026-11-14",
    "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/rainbow-shine-eih-k160079",
    "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": "rainbow Shine",
    "registry_name": "rainbow Shine",
    "url": "https://devicerts.com/devices/rainbow-shine-eih-k160079",
    "manufacturer": {
      "name": "GENOSS CO., Ltd.",
      "url": "https://devicerts.com/manufacturers/genoss-co-ltd",
      "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": "K160079",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "EIH"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "rainbow Shine is a dental material intended for use in restorative dentistry. It is a zirconia-based material used for the fabrication of dental crowns, bridges, and other prosthetic devices. The device is supplied as a pre-shaded or multi-layered block or disc for milling and sintering in the dental laboratory.\n\nThe device is manufactured by Genoss Co., Ltd. and is supplied in various sizes and configurations, including the catalog number SH9810WA1. It is intended for single-patient use and must be handled in accordance with standard infection control practices. The device is not evaluated for MRI safety and should be stored in a dry, cool environment. It received FDA 510(k) clearance under number K160079.",
      "ai_generated": true,
      "generated_on": "2026-09-21",
      "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": "K160079",
      "number_label": null,
      "device_udi_di": null,
      "date": "2016-11-10",
      "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": "K160079",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "EIH",
              "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 872.6660",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Dental",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}