{"publicDeviceRecordKey":"0736e3db-ec91-46ba-acf6-ab950a8929a2","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-05-15T00:00:00.000Z","devicePublishDate":"2026-05-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D775IBN0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Bonded Herbst","versionModelNumber":"IBN","catalogNumber":null,"dunsNumber":"041854332","companyName":"Great Lakes Dental Technologies, Ltd.","deviceCount":1,"deviceDescription":null,"DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K955822","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47528","gmdnPTName":"Palate-lifting sleep-disordered breathing orthosis","gmdnPTDefinition":"A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by elevating the soft palate (soft tissue constituting the back of the roof of the mouth). It works by applying pressure to retract and lift a drooping soft palate, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LRK","productCodeName":"Device, Anti-Snoring"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}