DeviceClearance

Product code ONK— General Hospital

ORALUBE

Classification name
Oral Lubricant
Device class
Class 1
Regulation
21 CFR 880.6375
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code ONK under 21 CFR 880.6375, via openFDA

Market context for product code ONK

FDA has cleared 1 device under product code ONK, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code ONK

Recent clearances under product code ONK

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