{"publicDeviceRecordKey":"1e5b5812-723e-4aee-81d5-685805e1c090","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-06-09T00:00:00.000Z","devicePublishDate":"2021-06-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08800053005265","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Drilling Guide Wheel","versionModelNumber":"DGW12","catalogNumber":null,"dunsNumber":"694721181","companyName":"DENTIS CO. ,LTD","deviceCount":1,"deviceDescription":"Dental Implant Instrument / Drilling Guide Wheel\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45123","gmdnPTName":"Endodontic stopper","gmdnPTDefinition":"A device that is used as a measuring reference point on an endodontic instrument used in a root canal procedure. It is typically designed as a flat ring made of an elastic material (e.g., silicone) that is placed at a predetermined distance from the distal end of the instrument (e.g., an endodontic file) allowing the operator to gauge the maximum depth of penetration. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NDP","productCodeName":"Accessories, Implant, Dental, Endosseous"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}