{"publicDeviceRecordKey":"20025e8f-161e-4e65-8f2e-580a57c1a75f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-02-06T00:00:00.000Z","devicePublishDate":"2023-11-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EDDIDDAASST35S1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DD Scanbody 2.0","versionModelNumber":"AAS 35/40 Set","catalogNumber":"DDAASST35S","dunsNumber":"313214171","companyName":"Dental Direkt GmbH","deviceCount":1,"deviceDescription":"DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw.\nThe Dental Direkt Scanbodies are used for digital acquisition of the implant position relative to the residual dentition and soft tissue.\nThe Dental Direkt Scanbodies are available for various implant systems, are intended for optical acquisition and are screwed into the implant as a placeholder for intraoral scans or into the laboratory analog in the dental model.","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":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+495225863190","phoneExtension":null,"email":"info@dentaldirekt.de"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61641","gmdnPTName":"Dental implant abutment analog, intraoral-scanning, single-use","gmdnPTDefinition":"An intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NDP","productCodeName":"Accessories, Implant, Dental, Endosseous"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Interface: 3.5mm and 4.0mm; Compatible with DENTSPLY Implants® Astra Tech® system"}]},"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":[]}}