{"publicDeviceRecordKey":"57aed0f4-6f8c-453a-b5c5-b4fc29be817a","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-04-06T00:00:00.000Z","devicePublishDate":"2026-03-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08435566642012","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"IPD","versionModelNumber":"TTI","catalogNumber":"IPD/DE-TN-00/C","dunsNumber":"467871518","companyName":"IMPLANT PROTESIS DENTAL 2004 SL","deviceCount":1,"deviceDescription":"Open Tray Coping Screw NT\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+13057983869","phoneExtension":null,"email":"burbina@ipd2004.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61646","gmdnPTName":"Dental prosthesis/implant abutment screw analog, reusable","gmdnPTDefinition":"A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NDP","productCodeName":"Accessories, 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":[]}}