{"publicDeviceRecordKey":"9ae571df-a20b-4015-b08c-05e8dab99370","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-05-22T00:00:00.000Z","devicePublishDate":"2025-05-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D769IMP90230","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"IMTEC ","versionModelNumber":"IM-P9023","catalogNumber":"P9023","dunsNumber":"011441508","companyName":"PARK DENTAL RESEARCH CORP","deviceCount":1,"deviceDescription":"2.0/3.3mm Paralleling Pins","DMExempt":true,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-243-7372","phoneExtension":null,"email":"info@pdrus.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31846","gmdnPTName":"Dental implantation depth/angle gauge, reusable","gmdnPTDefinition":"A device designed to be used during the planning and post-osteotomy stages of a dental implantation procedure, prior to surgical implant placement/fixation, to measure/determine various lengths (e.g., drill depth of the osteotomy cavity, mucosal height, distance between implants/teeth for determining the mesiodistal position of the implant) and/or angles [e.g., direction of the perforation in relation to the antagonist arch], typically to help select an appropriate final prosthetic abutment to be installed. It is typically graduated and may be a hand-held instrument or a stand-alone device placed intraorally; some types are intended for use during x-ray imaging. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NHA","productCodeName":"Abutment, Implant, Dental, Endosseous"}]},"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":[]}}