{"publicDeviceRecordKey":"cd051c5b-c8d3-4e92-b4e3-a771484bc404","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-11-03T00:00:00.000Z","devicePublishDate":"2020-03-19T00:00:00.000Z","deviceCommDistributionEndDate":"2021-11-16T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07540172016643","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Dual-Force™ Sectional Matrix System Complete Kit","versionModelNumber":"209015","catalogNumber":"209015","dunsNumber":"626406016","companyName":"CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.","deviceCount":1,"deviceDescription":"Collection of devices for direct restoration procedures","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)265-3444","phoneExtension":null,"email":"info@clinicianschoice.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62764","gmdnPTName":"Dental matrix band kit","gmdnPTDefinition":"A collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DZN","productCodeName":"INSTRUMENTS, DENTAL HAND"}]},"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":[]}}