<?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>acfae152-23cf-4474-9c1a-20f04abb316f</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2025-12-17</publicVersionDate><devicePublishDate>2021-06-20</devicePublishDate><deviceCommDistributionEndDate>2021-06-20</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D9436733</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>Power Dental USA</brandName><versionModelNumber>6733</versionModelNumber><catalogNumber>6733</catalogNumber><dunsNumber>081305064</dunsNumber><companyName>Power Dental U.S.A. Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>SUCTION TUBE 3.0 mm inside diameter / 4.8 mm outside diameter</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+1(815)363-8003</phone><phoneExtension xsi:nil="true"/><email>info@mydentalusa.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>38749</gmdnCode><gmdnPTName>Surgical/emergency suction cannula, non-illuminating, reusable</gmdnPTName><gmdnPTDefinition>An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn><gmdn><gmdnCode>34859</gmdnCode><gmdnPTName>Dental suction system</gmdnPTName><gmdnPTDefinition>An assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JOL</productCode><productCodeName>CATHETER AND TIP, SUCTION</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>