37e0b186-3111-48cf-a246-7f6eaf640803UpdatePublished32019-04-012016-09-232019-01-01Not in Commercial DistributionM595D5830PrimaryHIBCCPerioSonic®D583D583009900424PARKELL, INC.1PerioSonic Multi-Fluid Irrigator BasicfalsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse6312491134customerservice@parkell.com36047Ultrasonic 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, Ultrasonicfalsefalse