{"publicDeviceRecordKey":"2bd08a54-bf5d-449a-8dee-4cd9e56ee5c7","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2026-07-03T00:00:00.000Z","devicePublishDate":"2018-10-25T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07613353166649","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AIR-FLOW","versionModelNumber":"C","catalogNumber":"EL-354HF/C","dunsNumber":"481233849","companyName":"E.M.S. Electro Medical Systems S.A.","deviceCount":1,"deviceDescription":"PERIO-FLOW Handpiece White","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+41229944700","phoneExtension":null,"email":"udi@ems-ch.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K110173","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45403","gmdnPTName":"Chairside dental abrasive air jet system","gmdnPTDefinition":"An assembly of devices that comprises a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth/teeth. It typically consists of a control unit, a dedicated intraoral handpiece and a foot switch that enables the dentist to control the abrasion process; some types are known as a sandblaster. It has a variety of applications such as, the removal of plaque and stains, cleaning fissures, the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands, brackets), the removal of adhesive residue and the cleaning of implants prior to loading.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EFB","productCodeName":"Handpiece, Air-Powered, Dental"}]},"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}