{"publicDeviceRecordKey":"9e7c0ff5-3c02-420b-a856-bffc6d65314d","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-01-26T00:00:00.000Z","devicePublishDate":"2023-01-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00817169028024","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Hydrolux by 3D Dental","versionModelNumber":"HP-PB","catalogNumber":"HP-PB","dunsNumber":"080194935","companyName":"3D DENTAL DESIGNS AND DEVELOPMENT, LLC","deviceCount":1,"deviceDescription":"HYDROLUX PUSH BOTTON HANDPIECE","DMExempt":false,"premarketExempt":false,"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":"64225","gmdnPTName":"Pneumatic dental power tool system handpiece tip, reusable","gmdnPTDefinition":"A removable endpiece intended to be attached to a pneumatic dental power tool system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to mechanically fragment and/or cut bone tissue during a variety of dental surgery procedures, or to apply vibration during restoration placement. It is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is made of metallic or plastic materials; it is not intended to be held directly (i.e., does not include a holder). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EFB","productCodeName":"Handpiece, Air-Powered, Dental"}]},"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":[]}}