Sonendo

Summary

FDA records document multiple GentleWave system clearances, including K190359 for the GentleWave System and K203302 for GentleWave X. K203302 covers preparation, cleaning and irrigation of teeth indicated for root canal therapy, with the permitted tooth types dependent on the procedure instrument. The current G4 branding is presented as part of the manufacturer’s GentleWave family; older clearance names are retained in the underlying records. ^{[8][13][7][6][11][14][12][9][10][16][17][15][1][3]}

Two Class II recall records initiated October 14, 2022 concern erroneous outer-carton labels on specified lots of APM Procedure Instruments (GW-APM-PI02, lot W2022080941R) and Posterior CleanFlow Procedure Instruments (GW-PST-PI01, lot W2022080204R). FDA lists both records as open/classified. The notice stated that the products and inner pouch labels were unaffected and requested customer acknowledgement. ^{[8][13][7][6][11][14][12][9][10][16][17][15][1][3]}

A separate foot-pedal recall, initiated October 23, 2019, concerned continued console operation after the pedal was released. Customers were instructed to replace and return the affected pedal. FDA lists that recall as terminated January 20, 2022. These records identify specific instruments, lots and an earlier console accessory; they do not establish a recall of every current G4 configuration. ^{[8][13][7][6][11][14][12][9][10][16][17][15][1][3]}