<?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>ca0a1511-0c8a-418d-b6aa-8a006c070737</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2025-07-07</publicVersionDate><devicePublishDate>2019-07-09</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07332747159752</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>NobelSpeedy®</brandName><versionModelNumber>32141</versionModelNumber><catalogNumber>32141</catalogNumber><dunsNumber>353939929</dunsNumber><companyName>Nobel Biocare AB</companyName><deviceCount>1</deviceCount><deviceDescription>NobelSpeedy® Groovy WP 6.0x10mm</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>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)322-5001</phone><phoneExtension xsi:nil="true"/><email>us.customerservice@nobelbiocare.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>55849</gmdnCode><gmdnPTName>Screw endosteal dental implant, two-piece</gmdnPTName><gmdnPTDefinition>A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DZE</productCode><productCodeName>IMPLANT, ENDOSSEOUS, ROOT-FORM</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="10.000 "/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="6.000 "/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep away from sunlight. Keep dry</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>