{"publicDeviceRecordKey":"4da6e98a-7049-4235-999a-d46056186873","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-01-03T00:00:00.000Z","devicePublishDate":"2016-09-25T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033707071594","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"LEONE SPA","versionModelNumber":"001-0001-24","catalogNumber":"001-0001-24","dunsNumber":"432167294","companyName":"LEONE SPA","deviceCount":1,"deviceDescription":"KIT MINI ORTHODONTIC IMPLANTS\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46536","gmdnPTName":"Orthodontic anchoring screw","gmdnPTDefinition":"A small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NDP","productCodeName":"Accessories, Implant, Dental, Endosseous"},{"productCode":"EJL","productCodeName":"Bur, Dental"},{"productCode":"EKD","productCodeName":"Instrument, Cutting, Operative"},{"productCode":"OAT","productCodeName":"Implant, Endosseous, Orthodontic"}]},"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":[]}}