<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>1689fafb-1398-423f-b548-d036fa0d9020</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2025-07-31</publicVersionDate><devicePublishDate>2017-05-22</devicePublishDate><deviceCommDistributionEndDate>2025-07-30</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D867CLABP0</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Aqua Bond Sealant</brandName><versionModelNumber>CLABP</versionModelNumber><catalogNumber>CLABP</catalogNumber><dunsNumber>804495695</dunsNumber><companyName>Xemax Surgical Products Inc</companyName><deviceCount>1</deviceCount><deviceDescription>Aqua Bond Sealant is intended to increase adhession to wet or dry, normal and atypical enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel) and composite restorations without additional primers.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+0117072247817</phone><phoneExtension xsi:nil="true"/><email>customerservice@xemax.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>34782</gmdnCode><gmdnPTName>Dentine bonding agent/set</gmdnPTName><gmdnPTDefinition>A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KLE</productCode><productCodeName>AGENT, TOOTH BONDING, RESIN</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Store and handle at ambient temperatures.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>