c8000fe4-3a91-497d-898a-6f6da20bcee9UpdatePublished42018-07-312016-09-20In Commercial Distribution04719873120574PrimaryGS1PIEZO TIP BS-PFUBS-PFU657263687BONART CO., LTD.1falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling 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