Product code KZN— Dental

CHROMASCAN TM

Classification name
Scanner, Color
Device class
Class 2
Regulation
21 CFR 872.3661
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

Market context for product code KZN

FDA has cleared 2 devices under product code KZN between 1977 and 2007, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code KZN

Recent clearances under product code KZN

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