<?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>03bf3b9e-2b73-4a46-8021-f421f45c2325</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2021-02-05</publicVersionDate><devicePublishDate>2021-01-28</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08059224001050</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><identifier><deviceId>D821092CAN0</deviceId><deviceIdType>Previous</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>DENTAL ATTACHMENTS</brandName><versionModelNumber>OT CAP STANDARD size</versionModelNumber><catalogNumber>092CAN</catalogNumber><dunsNumber>439240722</dunsNumber><companyName>RHEIN 83 SRL</companyName><deviceCount>1</deviceCount><deviceDescription>KIT containing
- single spheres: SINGLE USE castable device to be transformed via casting technique in a metal attachment for removable prosthesis. 
- pink retentive caps: DISPOSABLE device in plastic material to be embodied in a removable prosthesis. Cap with soft retention.
- stainless steel housings: DISPOSABLE device used to contain the retentive cap inside the removable prosthesis.
- plastic positioners: SINGLE USE plastic device. Centering ring for castable housings.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</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/><gmdnTerms><gmdn><gmdnCode>44879</gmdnCode><gmdnPTName>Dental implant suprastructure, permanent, preformed</gmdnPTName><gmdnPTDefinition>A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EGG</productCode><productCodeName>Attachment, Precision, All</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>