7c782e52-3567-418b-a83b-c709976a2c77UpdatePublished32018-07-062016-09-22In Commercial Distribution07613353086701PrimaryGS1PIEZONcFS-287#A/004481233849E.M.S. Electro Medical Systems S.A.1Piezon built-in kit A-decfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+41229944700udi@ems-ch.comK05071000036047Ultrasonic dental scaling/debridement systemAn 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).falseActiveELCScaler, UltrasonicfalsetrueMoist Heat or Steam Sterilization