{"publicDeviceRecordKey":"08de7be5-5d0d-436c-8ca5-75402d5551f8","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-02-10T00:00:00.000Z","devicePublishDate":"2025-02-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D7091020064","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Promolux High Impact","versionModelNumber":"Promolux High Impact Polymer, C34, 100g","catalogNumber":"1020064","dunsNumber":"324914910","companyName":"Merz Dental GmbH","deviceCount":1,"deviceDescription":"Promolux High Impact Polymer, C34, 100g\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+494381403411","phoneExtension":null,"email":"claudia.bobrowski@merz-dental.de"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K130076","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"16730","gmdnPTName":"Dental appliance fabrication material, resin","gmdnPTDefinition":"A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EBI","productCodeName":"Resin, Denture, Relining, Repairing, Rebasing"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Weight","size":{"unit":"Gram","value":"100"},"sizeText":null,"sizeString":"Weight: 100 Gram"}]},"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}