{"publicDeviceRecordKey":"8425a905-29f3-4bfb-a731-54c63947ede0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-06-19T00:00:00.000Z","devicePublishDate":"2016-11-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00190746005299","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"2040 Ceramic Brackets","versionModelNumber":"002-1025B","catalogNumber":"002-1025B","dunsNumber":"044668515","companyName":"AMERICAN ORTHODONTICS CORPORATION","deviceCount":1,"deviceDescription":"COSMETIC 20/40 UR CUSP 022 T=0 A+11 R4M W/HK DIST","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(800)558-7687","phoneExtension":null,"email":"info@americanortho.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K922499","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}