Scaler, Ultrasonic

How Is ELC Classified?

Scaler, Ultrasonic is FDA product code ELC, Class 2, 21 CFR 872.4850.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 8 clearances under this code; the FDA took a median of 261 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 10 recalls under this product code since 2016. None was by a company in China. The root causes the FDA records most often are Process control (5), Error in labeling (2) and Device Design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.