{"publicDeviceRecordKey":"73e66971-8e30-4c02-aaa1-a1ed601f0987","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2023-12-06T00:00:00.000Z","devicePublishDate":"2016-09-20T00:00:00.000Z","deviceCommDistributionEndDate":"2023-12-04T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EBRE54TF2PB39","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"EBRE54TF2PB30","pkgQuantity":1,"pkgDiscontinueDate":"2016-09-20","pkgStatus":"Not in Commercial Distribution","pkgType":"dummy"},{"deviceId":"EBRE54TF2PB30","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"BioHPP TU for2press 100g","versionModelNumber":"54TF2PB3","catalogNumber":"54TF2PB3","dunsNumber":"341086190","companyName":"bredent GmbH \u0026 Co. KG","deviceCount":1,"deviceDescription":"BioHPP TU for2press 100g  1 Piece","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":[{"phone":"+4907309872451","phoneExtension":null,"email":"info@bredent.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37542","gmdnPTName":"Dental bridge, polymer","gmdnPTDefinition":"A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EBF","productCodeName":"MATERIAL, TOOTH SHADE, RESIN"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"keep dry"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"keep out of sunlight"}]},"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":[]}}