{"publicDeviceRecordKey":"362b01e5-f523-4c75-83af-d326d431e378","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-10-09T00:00:00.000Z","devicePublishDate":"2017-05-22T00:00:00.000Z","deviceCommDistributionEndDate":"2025-08-29T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D867CLEGS0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Etchant Gel Syringe","versionModelNumber":"CLEGS","catalogNumber":"CLEGS","dunsNumber":"804495695","companyName":"Xemax Surgical Products Inc","deviceCount":1,"deviceDescription":"Etchant Gel is 37% phosphoric acid (H3PO4) polymer-thickened and intended for use on enamel to prepare the surface for bonding. 6.5 gm push syringe of gel etchant with 20 tips.","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":"+0117072247817","phoneExtension":null,"email":"customerservice@xemax.com"}]},"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":"KLE","productCodeName":"AGENT, TOOTH BONDING, RESIN"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store at room temperature (15-30 Degrees C )"}]},"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":[]}}