<?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>28a26d9d-8218-4d5d-b528-3dc4620d17e6</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2025-09-16</publicVersionDate><devicePublishDate>2016-08-02</devicePublishDate><deviceCommDistributionEndDate>2025-09-15</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D6860131129</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>Waterpik Key-To Alginate Impression Material</brandName><versionModelNumber>013112-000</versionModelNumber><catalogNumber>013112-000</catalogNumber><dunsNumber>001804074</dunsNumber><companyName>WATER PIK, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Heavy Body, Fast Set</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</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>(800) 525-2020</phone><phoneExtension xsi:nil="true"/><email>professional@waterpik.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K970594</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>35863</gmdnCode><gmdnPTName>Alginate dental impression material</gmdnPTName><gmdnPTDefinition>A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient&apos;s teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ELW</productCode><productCodeName>Material, Impression</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Weight</sizeType><size unit="Pound" value="1"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="25"/><storageHandlingLow unit="Degrees Celsius" value="15"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>