DeviceClearance

Product code KZO— Dental

GOTHIC ARCH TRACING

Classification name
Ink, Arch Tracing
Device class
Class 1
Regulation
21 CFR 872.3150
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

Market context for product code KZO

FDA has cleared 2 devices under product code KZO between 1977 and 1981, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code KZO

Recent clearances under product code KZO

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