ONY

Oral Removable Retainer For Weight Management

Product code

ONY

Device name

Oral Removable Retainer For Weight Management

Device class

Class 2

21 CFR

21 CFR 876.5981

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

A removable oral device used during meals to limit food intake.

Definition text from the FDA device classification database (U.S. federal government work, public domain).