{"publicDeviceRecordKey":"8cfa24de-a79b-4476-b036-1869ba6c794a","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-03-30T00:00:00.000Z","devicePublishDate":"2023-03-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D1272425291","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Artman Instruments ","versionModelNumber":"242529","catalogNumber":"1","dunsNumber":"081170668","companyName":"Wise Linkers, LLC","deviceCount":1,"deviceDescription":"Dental Composite carver and Burnisher by Artman\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35793","gmdnPTName":"Dental restoration carver, amalgam, reusable","gmdnPTDefinition":"A hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EIY","productCodeName":"Instrument, Filling, Plastic, Dental"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}