{"publicDeviceRecordKey":"138d329d-7dd4-43d2-986c-83d925d9c642","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-09-13T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"8809447651514","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08809447651507","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"carton case"},{"deviceId":"08809447651507","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DENTA II","versionModelNumber":"DENTA II body","catalogNumber":null,"dunsNumber":"688282516","companyName":"Lutronic Corporation","deviceCount":1,"deviceDescription":"DENTA II body\n(DENTA II laser system)","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"215-205-2219","phoneExtension":null,"email":"jvojir@lutronic.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K091320","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47878","gmdnPTName":"Dental carbon dioxide laser system","gmdnPTDefinition":"A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite carbon dioxide (active medium) to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation for application in dental procedures, mainly to excise or vaporize tissue in the oral cavity. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It typically emits energy at a wavelength of 10,600 nm (far infrared) to tissues through a handpiece; it may be operated in continuous-wave or pulsed modes.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEX","productCodeName":"Powered Laser Surgical Instrument"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"40"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"70"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"30"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"30"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"20"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"70"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"30"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}