{"publicDeviceRecordKey":"b8e088d2-9b0f-4d03-8d77-d3312414dc38","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-01-31T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":"2017-09-14T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10190886008317","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00190886008310","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"VAPOR™ MBT CERAMIC BRACKETS","versionModelNumber":"76-U2-2LF-V","catalogNumber":null,"dunsNumber":"831465641","companyName":"G \u0026 H Wire Company, Inc.","deviceCount":5,"deviceDescription":"VAPOR™ MBT .022 UL2 +10°T +8°A\nVapor™ brackets are nearly invisible polycrystalline Ceramic Brackets manufactured through Ceramic Injected Molded – (CIM) Manufacturing. They are translucent in appearance, and aesthetically pleasing.  They have a revolutionary \"Portal\" Bonding Base; so adhesive flows through portals in the base for unprecedented mechanical bonds and optimal debonds.\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"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":"+1-317-346-6655","phoneExtension":null,"email":"orders@ghortho.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K132368","supplementNumber":"000"}]},"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}