45dbefe5-f86a-4702-af87-4359df5974c6UpdatePublished42021-04-132016-09-162017-12-31Not in Commercial Distribution04560264560437PrimaryGS1VariosVarios 560 LUX 120V690710546NAKANISHI INC.1falsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK06273100036047Ultrasonic 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