{"publicDeviceRecordKey":"36196f8b-0838-4ae5-89e5-15a3024ffd86","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2026-05-07T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D7091019178","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"M-PM Disc","versionModelNumber":"M-PM Disc, PMMA-Disc, shade D3 translucent ZIR thickness 20mm, diameter 95mm","catalogNumber":"1019178","dunsNumber":"324914910","companyName":"Merz Dental GmbH","deviceCount":1,"deviceDescription":"M-PM Disc, PMMA-Disc, shade D3 translucent ZIR thickness 20mm, diameter 95mm","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":"+4943814030","phoneExtension":null,"email":"regulatory@merz-dental.de"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K071548","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58288","gmdnPTName":"Dental appliance fabrication material, thermoplastic","gmdnPTDefinition":"A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EBG","productCodeName":"Crown And Bridge, Temporary, Resin"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"95"},"sizeText":null,"sizeString":"Outer Diameter: 95 Millimeter"},{"sizeType":"Height","size":{"unit":"Millimeter","value":"20"},"sizeText":null,"sizeString":"Height: 20 Millimeter"}]},"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}