{"publicDeviceRecordKey":"658fcd0a-da1f-4b86-85c8-30e6874fc841","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-08-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D6583498281","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NATURE-CRYL®","versionModelNumber":"349828","catalogNumber":"349828","dunsNumber":"005473608","companyName":"Gc America Inc.","deviceCount":1,"deviceDescription":"NATURE-CRYL®  SUPER HI IMPACT MILD 25lb POWDER","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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(708)597-0900","phoneExtension":null,"email":"customerservice@gcamerica.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K051358","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"16729","gmdnPTName":"Denture base resin, heat-cured","gmdnPTDefinition":"A resin that requires heat for polymerization intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually consists of an acrylic monomer of methyl methacrylate (typically supplied as a powder) that becomes a polymer (polymethylmethacrylate or PMMA) when mixed with a catalyst such as benzoylperoxide (typically supplied as a liquid). Reinforcing fillers may be included in the resin to increase its strength and/or durability. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"EBI","productCodeName":"RESIN, DENTURE, RELINING, REPAIRING, REBASING"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Weight","size":{"unit":"Pound","value":"25"},"sizeText":null,"sizeString":"Weight: 25 Pound"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"80"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"60"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"27"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"15"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}