{"publicDeviceRecordKey":"71381323-8530-47e1-802a-4dc3f7fa018d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-10-09T00:00:00.000Z","devicePublishDate":"2016-08-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D801SP7012N1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SciPharm Gel Etch Dental Conditioner","versionModelNumber":"SP 70-12 N","catalogNumber":"70-12","dunsNumber":"096010525","companyName":"SCIENTIFIC PHARMACEUTICALS, INC.","deviceCount":1,"deviceDescription":"Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes.  12 grams Green Gel Etch Syringe.  Non-Boxed.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"800-634-3047","phoneExtension":null,"email":"Denise@scipharm.com"},{"phone":"909-595-9922","phoneExtension":null,"email":"Denise@scipharm.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K872569","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"36153","gmdnPTName":"Dental tooth-etching solution","gmdnPTDefinition":"An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EBF","productCodeName":"Material, Tooth Shade, Resin"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"83"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","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}