{"publicDeviceRecordKey":"7323ce73-9781-48ab-84ba-242f0d94cefc","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-03-30T00:00:00.000Z","devicePublishDate":"2021-08-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07630031753663","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Straumann RidgeFit Implants","versionModelNumber":"Mini Implants","catalogNumber":"042.955S","dunsNumber":"483599259","companyName":"Institut Straumann AG","deviceCount":1,"deviceDescription":"Straumann® RidgeFit Implant, Ø 2.4mm, GH 3.8mm, SLA®, 12mm, TiN, Roxolid®","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(801)448-8168","phoneExtension":null,"email":"info.usa@straumann.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"55848","gmdnPTName":"Screw endosteal dental implant, one-piece","gmdnPTDefinition":"A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DZE","productCodeName":"IMPLANT, ENDOSSEOUS, ROOT-FORM"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"12"},"sizeText":null,"sizeString":"Length: 12 Millimeter"},{"sizeType":"Height","size":{"unit":"Millimeter","value":"3.8"},"sizeText":null,"sizeString":"Height: 3.8 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"2.4"},"sizeText":null,"sizeString":"Outer Diameter: 2.4 Millimeter"}]},"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":[]}}