<?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>9e7c0ff5-3c02-420b-a856-bffc6d65314d</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-01-26</publicVersionDate><devicePublishDate>2023-01-18</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00817169028024</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Hydrolux by 3D Dental</brandName><versionModelNumber>HP-PB</versionModelNumber><catalogNumber>HP-PB</catalogNumber><dunsNumber>080194935</dunsNumber><companyName>3D DENTAL DESIGNS AND DEVELOPMENT, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>HYDROLUX PUSH BOTTON HANDPIECE</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>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>64225</gmdnCode><gmdnPTName>Pneumatic dental power tool system handpiece tip, reusable</gmdnPTName><gmdnPTDefinition>A removable endpiece intended to be attached to a pneumatic dental power tool system handpiece for the application of sonic vibrational energy (e.g., at a frequency of 6 kHz) to mechanically fragment and/or cut bone tissue during a variety of dental surgery procedures, or to apply vibration during restoration placement. It is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is made of metallic or plastic materials; it is not intended to be held directly (i.e., does not include a holder). This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EFB</productCode><productCodeName>Handpiece, Air-Powered, Dental</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>