<?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>fd46ee0a-be23-48d5-be21-92658ab8c30a</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2019-01-14</publicVersionDate><devicePublishDate>2018-12-14</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07613353172015</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>AIR-FLOW</brandName><versionModelNumber>D</versionModelNumber><catalogNumber>FT-221#HF/A/006</catalogNumber><dunsNumber>481233849</dunsNumber><companyName>E.M.S. Electro Medical Systems S.A.</companyName><deviceCount>1</deviceCount><deviceDescription>AIR-FLOW® handy 3.0 PERIO</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</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>true</rx><otc>false</otc><contacts><customerContact><phone>+41229944700</phone><phoneExtension xsi:nil="true"/><email>udi@ems-ch.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K132480</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>45406</gmdnCode><gmdnPTName>Dental abrasive air jet system handpiece</gmdnPTName><gmdnPTDefinition>A hand-held, dental device that is a component of a dental abrasive air jet system and which is used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient&apos;s tooth or teeth. This device is connected to the control unit that regulates the sources of pressurized air and temperate water. The abrasive, typically in the form of a powder that, depending upon the design of the delivery method, can be contained within a receptacle in this device or a receptacle within the control unit, is mixed with the air and water as this passes through. 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>