<?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>4b2c5d7e-ffaa-48d2-8573-8653694c7763</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2025-10-29</publicVersionDate><devicePublishDate>2024-08-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00887482113752</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>Symmetry House</brandName><versionModelNumber>61-0363</versionModelNumber><catalogNumber>61-0363</catalogNumber><dunsNumber>027680821</dunsNumber><companyName>ASPEN SURGICAL PRODUCTS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Symmetry® Excavator, House &quot;Hoe&quot; Hough, Tip Angled 90° Straight Shaft, 0.5 mm Tip, 6 1/2 in</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</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>+1 888-364-7004</phone><phoneExtension xsi:nil="true"/><email>customerservice@symmetrysurgical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35811</gmdnCode><gmdnPTName>Dental excavator, reusable</gmdnPTName><gmdnPTDefinition>A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JYH</productCode><productCodeName>Excavator, Ear</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="0.5"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Angle</sizeType><size unit="degree" value="90"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Inch" value="6.5"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>