<?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>e9a87403-2de9-485f-8cd2-b752d511aeda</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-05-15</publicVersionDate><devicePublishDate>2023-05-05</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>EMICTPENMS1</deviceId><deviceIdType>Primary</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>Enamel Plus Stain &amp; Instruments</brandName><versionModelNumber>TPENMS</versionModelNumber><catalogNumber>TPENMS</catalogNumber><dunsNumber>436661136</dunsNumber><companyName>MICERIUM SPA</companyName><deviceCount>1</deviceCount><deviceDescription>Enamel Plus Stain and Instruments
- 5 Spare blue rubber brush tips sterilizable
- 190/180 degrees titl metal handle for compiste modelling </deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</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>false</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>63953</gmdnCode><gmdnPTName>Dental material application tool, reusable</gmdnPTName><gmdnPTDefinition>A hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EJB</productCode><productCodeName>Handle, Instrument, Dental</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>