{"publicDeviceRecordKey":"a56f6a66-8882-4e13-8d14-7bfa6b6c3095","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2022-08-03T00:00:00.000Z","devicePublishDate":"2017-06-12T00:00:00.000Z","deviceCommDistributionEndDate":"2022-08-02T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D757B32110","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Bis-Silane","versionModelNumber":"B-3211","catalogNumber":"B-3211","dunsNumber":"053529939","companyName":"BISCO INC.","deviceCount":1,"deviceDescription":"Bis-Silane Primer Part A 6ml","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(847)534-6000","phoneExtension":null,"email":"sales@bisco.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K874557","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62474","gmdnPTName":"Dental prosthesis priming agent","gmdnPTDefinition":"A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EBC","productCodeName":"SEALANT, PIT AND FISSURE, AND CONDITIONER"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"25"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"20"},"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}