ONK

Oral Lubricant

Product code

ONK

Device name

Oral Lubricant

Device class

Class 1

21 CFR

21 CFR 880.6375

Medical specialty

General Hospital

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

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

FDA classification definition

An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.

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