DeviceClearance

Product code QGO— Dental

Compex HD

Classification name
Composite Resin Warmer
Device class
Class 1
Regulation
21 CFR 872.6100
Advisory panel
Dental
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended to warm composite materials prior to use”

— U.S. Food and Drug Administration, device classification record for product code QGO under 21 CFR 872.6100, via openFDA

Market context for product code QGO

FDA has cleared 1 device under product code QGO, all in 2019, 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 QGO

Recent clearances under product code QGO

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