{"publicDeviceRecordKey":"69009557-c9a3-4fab-b439-4bd58bc81fc4","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":"D0470091801","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"D0470091800","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"G-aenial™","versionModelNumber":"009180","catalogNumber":"009180","dunsNumber":"005473608","companyName":"Gc America Inc.","deviceCount":10,"deviceDescription":"G-aenial™ Sculpt 10 Unitip A03 (0.16mL each)","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"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":"K123631","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38764","gmdnPTName":"Light-cured dental restorative composite resin","gmdnPTDefinition":"A dental restorative material that consists of a blend of filler particles (e.g., glass, ceramic, zirconia, silica) mixed with a synthetic, photo-polymerizable, organic resin matrix [e.g., bisphenol A-glycidyl methacrylate (BISGMA), urethane dimethacrylate (UDMA)] intended to fill dental cavities or restore damaged hard dental tissue. It is typically a one-part paste, contained within an application syringe or capsule, that requires a light source of specific wavelengths (e.g., 460 to 480 nm) to initiate resin polymerization/hardening post application; it is typically available in tooth-coloured shades. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"EBF","productCodeName":"MATERIAL, TOOTH SHADE, RESIN"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"77"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"39"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"25"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"4"},"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}