DeviceClearance

Product code ELC— Dental

Sonendo GentleWave System

Classification name
Scaler, Ultrasonic
Device class
Class 2
Regulation
21 CFR 872.4850
Advisory panel
Dental
Total cleared
195
First cleared
Most recent

Market context for product code ELC

FDA has cleared 195 devices under product code ELC between 1976 and 2026, filed by 102 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code ELC

Adverse events under product code ELC

product code ELC
Malfunction
1,255
Total
1,255

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code ELC

1–100 of 195

Data sourced from openFDA. This site is unofficial and independent of the FDA.