<?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>c072c8df-77d7-425e-9cb5-c7841d2893a8</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-12-05</publicVersionDate><devicePublishDate>2022-11-25</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07506338317962</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>QUARZ, MDC Dental</brandName><versionModelNumber>Rápido R1V</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>811180298</dunsNumber><companyName>MDC DENTAL</companyName><deviceCount>1</deviceCount><deviceDescription>NIC TONE QUARZ Rapid Acrylic R1V 2.5 Kg
</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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>3338330333</phone><phoneExtension xsi:nil="true"/><email>tecnovigilancia@dental.com.mx</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K991577</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>63591</gmdnCode><gmdnPTName>Dental acrylic resin</gmdnPTName><gmdnPTDefinition>A non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EBG</productCode><productCodeName>Crown And Bridge, Temporary, Resin</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>