{"publicDeviceRecordKey":"1b8308b3-e4ed-40c6-a585-f77cd93d0d38","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-05-19T00:00:00.000Z","devicePublishDate":"2023-05-11T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00990010302020","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Comfort-Sonic ","versionModelNumber":"UL2104","catalogNumber":"Comfort-Sonic LED Scaler P6 Plus","dunsNumber":"244261462","companyName":"Beyes Dental Canada Inc","deviceCount":1,"deviceDescription":"Comfort-Sonic LED Scaler P6 Plus,Includes 6 tips ( EE1, 2 EG1, EG2, EG4, EP1)","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K053555","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"36047","gmdnPTName":"Ultrasonic dental scaling/debridement system","gmdnPTDefinition":"An assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ELC","productCodeName":"Scaler, Ultrasonic"}]},"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}