{"publicDeviceRecordKey":"1083a39d-256f-405a-89d6-d25a1534e9b1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-07-07T00:00:00.000Z","devicePublishDate":"2019-07-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07332747161069","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NobelSpeedy®","versionModelNumber":"37686","catalogNumber":"37686","dunsNumber":"353939929","companyName":"Nobel Biocare AB","deviceCount":1,"deviceDescription":"NobelSpeedy® Groovy RP 5.0x8.5mm","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(800)322-5001","phoneExtension":null,"email":"us.customerservice@nobelbiocare.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"55849","gmdnPTName":"Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, 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":"Outer Diameter","size":{"unit":"Millimeter","value":"5.000 "},"sizeText":null,"sizeString":"Outer Diameter: 5.000  Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"8.500 "},"sizeText":null,"sizeString":"Length: 8.500  Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep away from sunlight. Keep dry"}]},"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":[]}}