{"publicDeviceRecordKey":"44913c50-34ac-4fcb-8edb-db698a6673c7","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-02-23T00:00:00.000Z","devicePublishDate":"2016-04-29T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D785OSTOSCKIT0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Concave Tip Offset Osteotome Kit ","versionModelNumber":"Concave Tip Offset Osteotome Kit  (3)","catalogNumber":"OST-OS-C Kit","dunsNumber":"094146123","companyName":"OCO BIOMEDICAL INC","deviceCount":1,"deviceDescription":"Concave Tip Offset Osteotome Kit  (3)\nAll 3 with case\n2.65mm Concave Tip Offset Osteotome \n3.4mm Concave Tip Offset Osteotome \n4.4mm Concave Tip Offset Osteotome ","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"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":"44886","gmdnPTName":"Dental osteotome set","gmdnPTDefinition":"A collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DZN","productCodeName":"Instruments, Dental Hand"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}