{"publicDeviceRecordKey":"5c140364-742a-4dc2-a7b5-415f9e36afd8","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2023-08-02T00:00:00.000Z","devicePublishDate":"2020-11-02T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04952195089406","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Quolis","versionModelNumber":"Quolis","catalogNumber":"AU-BDS5170","dunsNumber":"690540349","companyName":"TAKARA BELMONT CORP.","deviceCount":1,"deviceDescription":"QUOLIS PMU WITH ASSISTANT ARM","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"732 4695000","phoneExtension":null,"email":"gstern@belmonteqip.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K072273","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34991","gmdnPTName":"Dental delivery system","gmdnPTDefinition":"A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NRD","productCodeName":"Unit, Operative Dental, Accessories"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}