{"publicDeviceRecordKey":"5c58d2cd-af5f-4b62-9bf4-11c8ff29bfac","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-04-18T00:00:00.000Z","devicePublishDate":"2020-08-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"ESAM5302000","deviceIdType":"Direct Marking","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"ESAM5302001","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"STOMA®","versionModelNumber":"5302.00","catalogNumber":"5302.00","dunsNumber":"318268125","companyName":"Storz am Mark GmbH","deviceCount":1,"deviceDescription":"Crown remover, Treymann","DMExempt":false,"premarketExempt":true,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+49746592600","phoneExtension":null,"email":"sam@stoma.de"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"64422","gmdnPTName":"Dental prosthesis removal instrument","gmdnPTDefinition":"A non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration; some types are referred to as crown spreaders. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EIS","productCodeName":"REMOVER, CROWN"}]},"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":[]}}