Product code ONK

Device name

Oral Lubricant

Medical specialty

General Hospital

Device class

1

Regulation number

880.6375

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset