{"publicDeviceRecordKey":"2697c4ed-50bc-487c-b74e-8fa25b4f62a2","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2018-12-20T00:00:00.000Z","devicePublishDate":"2017-05-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D77819910550","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SELECT TEMPORARY FILLING MATERIAL 30 GM JAR","versionModelNumber":"199-1055","catalogNumber":"199-1055","dunsNumber":"137217043","companyName":"SCOTT'S DENTAL SUPPLY L.L.C.","deviceCount":1,"deviceDescription":"Scott’s Select Temporary Filling material is indicated for the temporary filling of root canal access opening, cavity preparations that require temporary fillings for short periods during therapeutic treatment and temporary filling for small inlay preparations. Scotts Select Temporary filling material is a single paste that can be applied by spatula. It sets with a slight expansion to a hard material that can be removed without the use of burs. It is a non-eugenol formulation allowing it to be applied in locations where a resin such as a composite restorative or bonding system will be used in the final restorative technique. Instructions for use and SDS available at https://www.scottsdental.com/temporary-filling-material-scott-s-select.html","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":"800-901-3368","phoneExtension":null,"email":"info@scottsdental.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"16705","gmdnPTName":"Zinc polycarboxylate dental cement","gmdnPTDefinition":"A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EMA","productCodeName":"Cement, Dental"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Weight","size":{"unit":"Gram","value":"30"},"sizeText":null,"sizeString":"Weight: 30 Gram"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"25"},"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":{"gmdn_code":"16705","anomaly_score":-0.0000053507645857431285},"premarketSubmissions":{"premarketSubmission":[]}}