{"publicDeviceRecordKey":"75938340-4933-4d2d-98f7-bd32ceead0cf","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-04-05T00:00:00.000Z","devicePublishDate":"2017-06-26T00:00:00.000Z","deviceCommDistributionEndDate":"2021-01-15T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D807110212901","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"D807110212900","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MYSTIQUE® MB","versionModelNumber":"110-212-90","catalogNumber":"110-212-90","dunsNumber":"116903307","companyName":"DENTSPLY SIRONA ORTHODONTICS INC.","deviceCount":10,"deviceDescription":"MYSTIQUE® MB  Roncone 022/UL1 18T 5A","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(631)357-8600","phoneExtension":null,"email":"CustomerService_GAC@dentsplysirona.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58937","gmdnPTName":"Orthodontic bracket, ceramic","gmdnPTDefinition":"A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NJM","productCodeName":"Bracket, ceramic, orthodontic"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}