45180a11-058e-49eb-9c1b-9203520ae431UpdatePublished32018-07-062016-09-20In Commercial Distribution04719873120376PrimaryGS1TORQUE WRENCHPS0007-362R657263687BONART CO., LTD.1falsefalsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK07198100036047Ultrasonic 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