{"publicDeviceRecordKey":"ae63253f-98ec-4acb-bbcf-109032f6e8a9","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-11-03T00:00:00.000Z","devicePublishDate":"2025-10-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840018668317","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Nordent Manufacturing, Inc. ","versionModelNumber":"Hartzell Gracey 11 Rigid","catalogNumber":"N/A","dunsNumber":"053187985","companyName":"NORDENT MANUFACTURING INC","deviceCount":1,"deviceDescription":"Scaler, Cone Socket Tip, Hartzell Gracey 11 Rigid, SST\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":true,"contacts":{"customerContact":[{"phone":"8474374780","phoneExtension":null,"email":"ashah@nordent.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35320","gmdnPTName":"Manual dental scaler, reusable","gmdnPTDefinition":"A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ELA","productCodeName":"Instrument, Hand, Calculus Removal"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Inch","value":"6.5"},"sizeText":null,"sizeString":"Length: 6.5 Inch"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"60"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"40"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"350"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"0"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"60"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"40"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"75"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"65"},"storageHandlingSpecialConditionText":null}]},"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":[]}}