{"publicDeviceRecordKey":"3632e5b4-d576-4715-981c-96547e6b3754","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-10-09T00:00:00.000Z","devicePublishDate":"2016-09-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D83600540","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Dental Etchant (Enamel Conditioner), 1kg Bottle","versionModelNumber":"0054","catalogNumber":"0054","dunsNumber":"789664455","companyName":"DENT ZAR, INC.","deviceCount":1,"deviceDescription":"Etch Gel-available for bulk purchase-1 kg bottle. Dent Zar’s etch gel is a 37% phosphoric acid solution. \n•\tConvenient dispensing system with disposable tips\n•\tEasy to wash off\n•\tEconomical\n•\tColored for precise application\n•\tExcellent wetting characteristics\n•\tNon-drying\n•\tDirect to tooth application with disposable luer-lock tips\n•\tRefillable applicator syringes\n","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"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":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}